Operation Manual Ero - Scan: Screening and Diagnostic Version

Operation Manual
ERO•SCAN®
Screening and Diagnostic Version
Operation Manual ERO•SCAN®
Table of Contents
Trademark Notice ................................................................
......................................................................................
...................................................... 4
1 Standards Compliance................................................................
..........................................................................
.......................................... 5
2 Warranty ................................................................
.............................................................................................
............................................................. 6
2.1 Intended Use ............................................................................... 6
2.2 Indications for Use ....................................................................... 6
3 Warnings, Cautions and Errors ..............................................................
.............................................................. 7
3.1 Status/Error Messages .................................................................. 9
4 Customer Responsibility................................
Responsibility................................................................
......................................................................
...................................... 11
5 Safety Precautions ................................................................
..............................................................................
.............................................. 12
5.1 Cautions - General ..................................................................... 12
5.2 Warning - Electric Shock Hazards................................................ 13
5.3 Warning - In Case of Emergency ................................................ 13
5.4 Warning - Explosion ................................................................... 13
5.5 Warning - Battery Safety ............................................................ 13
5.6 Warning - General ..................................................................... 13
6 Recycling/Disposal ................................................................
..............................................................................
.............................................. 14
7 Regulatory Symbols ................................................................
............................................................................
............................................ 15
8 Introduction
Introduction................................
uction................................................................
.......................................................................................
....................................................... 17
8.1 How Does the ERO•SCAN® Device Work? .................................. 17
8.2 How are the Results Stored and Reported? ................................. 18
8.3 Sensitivity and Specificity ............................................................ 18
9 Setup ................................................................
................................................................................................
................................................................ 19
9.1 Unpacking the System ................................................................ 19
9.2 Battery Charging........................................................................ 19
9.3 Installing the Micro-Probe........................................................... 20
9.4 Attaching Eartips ....................................................................... 21
9.5 Removing Eartips ....................................................................... 21
10 Operating Instructions ................................................................
........................................................................
........................................ 22
10.1 Preparing the Patient for Testing ................................................ 22
10.2 Turning On the Instrument ......................................................... 22
10.3 Control Panel ............................................................................. 22
10.4 Main Menu ................................................................................ 23
10.5 Selecting the Test Protocol ......................................................... 23
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10.6 Probe Check (Beginning a Test) .................................................. 24

10.7 Calibration and Test ................................................................... 25
10.8 Viewing Results .......................................................................... 25
10.9 Test Technique........................................................................... 26
10.10 Noise Sources ............................................................................ 26
10.11 TEOAE and Pause Function ......................................................... 27
10.12 Turning Off the Instrument......................................................... 27
11 Managing Results ................................................................
..............................................................................
.............................................. 28
11.1 Saving Results ............................................................................ 28
11.2 Deleting Results ......................................................................... 29
11.3 Printing to a Thermal Printer ....................................................... 29
11.4 Connecting to the PC Database Software ................................... 30
11.5 Connecting to the Direct-to-Print Software ................................. 30
12 MPT-
MPT-II SANIBEL Mobile thermal mini printer .........................................
......................................... 32
12.1 Operation .................................................................................. 33
13 Interpreting
Interpreting Results ................................................................
............................................................................
............................................ 36
13.1 Understanding the Display.......................................................... 36
13.2 SNR Graph View ........................................................................ 37
13.3 Value Graph View ...................................................................... 37
14 Interpreting
Interpreting Printed Results ................................................................
.................................................................
................................. 38
14.1 Understanding the DPOAE Printout ............................................ 38
14.2 Understanding the TEOAE Printout ............................................. 39
15 Rounding Results ................................................................
...............................................................................
............................................... 40
16 Clock and Date Settings ................................................................
.....................................................................
..................................... 41
16.1 Accessing the Clock Menu ......................................................... 41
16.2 Changing the Date/Time ............................................................ 41
17 Instrument Settings ................................................................
............................................................................
............................................ 42
17.1 Wireless Device Pairing – Thermal Printer .................................... 42
17.2 Clearing Test Results .................................................................. 43
17.3 Auto Shutdown Time ................................................................. 43
17.4 Save Mode/Storing Test Results .................................................. 44
17.5 Minimum Amplitude .................................................................. 45
17.6 Clock Mode ............................................................................... 45
17.7 Graph Style ................................................................................ 45
17.8 Boys Town Norms ...................................................................... 46
17.9 Language .................................................................................. 46
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17.10 Reset to Default ......................................................................... 47

18 Advanced Options for DPOAE Testing .................................................
................................................. 48
18.1 Instructions for Customizing a Test Protocol................................ 48
18.2 Selecting the Level of Primary Tones ........................................... 49
18.3 Setting the Averaging Time ........................................................ 49
18.4 Setting the PASS SNR Level......................................................... 49
18.5 Setting the Number of Frequencies for PASS ............................... 50
18.6 Reset Protocol ............................................................................ 50
18.7 Save Protocol ........................................................................... 50
19 Advanced Options for TEOAE Testing ..................................................
.................................................. 51
19.1 Instructions for Customizing a Test Protocol................................ 51
19.2 Selecting the Averaging Time ..................................................... 52
19.3 Setting the PASS SNR Level......................................................... 52
19.4 Setting the Number of Frequencies for PASS ............................... 53
19.5 Reset Protocol ............................................................................ 53
19.6 Save Protocol ............................................................................. 53
20 Cleaning and Maintenance ................................................................
.................................................................
................................. 54
20.1 Cleaning and Disinfection .......................................................... 54
20.2 Maintenance.............................................................................. 55
20.3 Probe Tube Replacement ............................................................ 55
21 Troubleshooting................................................................
.................................................................................
................................................. 56
22 Specifications
Specifications................................................................
.....................................................................................
..................................................... 59
Appendix A: Flowcharts ................................................................
...........................................................................
........................................... 61
A.1 Test Operation Flowchart ................................................................ 61
A.2 Setup Menu Flowchart ................................................................... 62
Appendix
Appendix B: Test Sequence ................................................................
......................................................................
...................................... 63
Appendix C: Pass/Refer Criteria ................................................................
................................................................ 65
Appendix D: Configurations and Test Protocols .........................................
......................................... 68
Appendix E: EMC Compatibility ................................................................
................................................................ 69
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Title: ERO•SCAN® Screening and Diagnostic Version – Operation Manual
MAICO Diagnostics
10393 West 70th Street
Eden Prairie, MN 55344
Tel.: 888.941.4201
Fax: 952.903.4100
E-mail: info@maico-diagnostics.com
Internet: www.maico-diagnostics.com
Copyright © 2015
2015 MAICO Diagnostics
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.
Trademark Notice
ERO•SCAN® is a U.S. registered trademark of Etymotic Research, Inc.
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1 Standards Compliance
Issue
Standard Date Title
ANSI/ASA 3.6 2010 Specification for Audiometers

ANSI/AAMI 2005 Medical Electrical Equipment – General Requirements for
60601-1 Basic Safety and Essential Performance, Ed. 3
IEC 60645-1 2004 Electroacoustics - Audiological equipment -- Part 1: Pure-
tone audiometers
IEC 60645-3 2007 Electroacoustics - Audiometric equipment -- Part 3: Test
signals of short duration
IEC 60645-6 2010 Electroacoustics – Audiometric Equipment – Part 6:
Instruments for the measurement of otoacoustic emissions
ISO 14971 2007 Application of Risk Management to Medical Devices
ISO 10993 2009 Biological Evaluation of Medical Devices
EN 60601-1-2 2007 Medical electrical equipment -- Part 1-2: General

requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and Tests.
FCC Part 15 FCC 47CFR, Part 15..247 & 15.249
IEC 60601-1 2005 Clause 8.9.1.8; Pollution Degree Classification: 2
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2 Warranty
MAICO Diagnostics warrants that this product is free from defects in material and
workmanship and, when properly used, will perform in accordance with applicable
specifications. If this instrument does not meet these criteria within one year of original
shipment, it will be repaired, or at our option, replaced at no charge when returned to our
service facility.
NOTE: Changes in the product not approved by MAICO Diagnostics shall void this warranty.
MAICO Diagnostics shall not be liable for any indirect, special or consequential damages,
even if notice has been given of the possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,

INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
For assistance with this ERO•SCAN® Otoacoustic Emission Test System contact your Special
Equipment Distributor or contact MAICO Diagnostics by phone at 888.941.4201 or by fax
at 952.903.4100.
2.1 Intended Use

The ERO•SCAN® is a test instrument that measures otoacoustic emissions in infants,
children, and adults.
2.2 Indications for Use

The ERO•SCAN® is indicated for testing of cochlear function in infants, children and adults
by measuring otoacoustic emissions (OAEs). 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.
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3 Warnings, Cautions and Errors

In this manual the following two labels identify potentially dangerous or destructive
conditions and procedures.
WARNING The WARNING label identifies conditions or practices that may

present danger to the patient and/or user.
CAUTION 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 The ERO•SCAN® Otoacoustic Emission Test System should be

charged using only the provided power supply. Injury to personnel
or damage to equipment can result when a three-prong to two-
prong adaptor is connected between the ERO•SCAN® power supply
and an AC outlet.
No modifications of the equipment are allowed by anyone other

than a qualified MAICO representative. Modification of the
equipment could be hazardous.
The ERO•SCAN® product 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 instrument in proximity with other
devices or equipment that may emit or be susceptible to
electromagnetic interference, including mobile phones. If the
instrument is used adjacent to other devices or equipment, the user
is instructed to verify that no disturbance is found in the operation
of this or other equipment in proximity.
This icon indicates that patient applied parts of the instrument

conform to IEC 60601-1:2005, Type B requirements.
CAUTION
US federal law restricts this device to sale by or on the order of a
physician or licensed hearing care professional.
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Instruments which bear the Underwriters Laboratories, Inc. label

should be interconnected with accessories that have the proper
electrical compatibility and are listed as meeting the requirements of
the UL Medical and Dental Equipment Standard. Connection of
accessories not meeting these requirements may result in electrical
leakage currents in excess of those allowed by the standard and
present a potential electrical shock hazard to the person being
tested.
Any program aimed at obtaining reliable measurements of

otoacoustic emissions should be staffed and supervised by
appropriately-trained individuals.
This device complies with part 15 of the FCC Rules. Operation is

subject to the condition that this device does not cause harmful
interference.
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3.1 Status/Error Messages

Display Messages:
Attach Probe No probe is detected at the start of a test.

BT Device Not The paired wireless device cannot be detected. The device may be turned off
Found or too far away.
BT Error #xxx There is an error condition with the wireless device. Check the status.
BT Not The ERO•SCAN® instrument is not paired with any wireless device.
Configured
Device not The printer is not responding to queries from the instrument.
Responding
Due For Service Indicates calibration of instrument is recommended. Message will appear
upon the calibration due date set in the device. Message appears during
device startup once per day.
Fit Error For a DP test, the desired level (L1 or L2) cannot be obtained within
Cannot Obtain L allowable limits. User should refit the probe and retry the test.
Fit Error For a DP test, the level of the calibration tone is too high. User should refit
Too High the probe and retry the test.
Fit Error For a DP test, the level of the calibration tone is too low. User should refit the
Too Low probe and retry the test.
Limit Error Overflow error during the calculation of the DFTs for a DP test. User should
repeat the test.
Memory Almost Saved tests are within 5 tests of the maximum limit.
Full
Memory Full! The maximum saved test limit is reached. The user will need to clear the
memory before any additional tests can be performed.
Power Low! The battery charge level is too low for operation. The user must charge the
battery before additional tests can be performed.
Printer Error Indicates a problem with the printer. Check the printer status.
Printer Paper Indicates that printer paper has run out.
Out!
Time/Date Error The clock is checked during power on to ensure it has not lost time and been
reset. In the case of clock reset, this message is shown. The user should set
the correct date/time.
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Indicator LEDs (lights):
NOISE / Orange The indicator labeled ‘NOISE’ provides a visual indication (AMBER) that the
noise level measured during the test exceeds a nominal threshold.
Also used to indicate some error conditions and when the outcome of test is
REFER, NOISY, or NO SEAL.
TEST / Yellow The indicator labeled ‘TEST’ provides a visual indication (YELLOW) that the
selected test is being performed. This indicator will remain on steady state
during the test function.
READY / Green The indicator labeled ‘READY’ lets the user know that the instrument is not
currently performing a test function and that it is available to perform a test
function.
CHARGE / Blue The indicator labeled ‘CHARGE’ provides a visual indication (BLUE) of the
battery recharging function and battery status. The rate of illumination of the
indicator provides a means of identifying the status of the charging function.
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4 Customer Responsibility
WARNING
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 should not 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.
This product should not be used 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 use in the presence of flammable gaseous mixtures. Users

should consider the possibility of explosions or fire when using this
device in close proximity to flammable anesthetic gases.
Do NOT use the ERO•SCAN® in a highly oxygen-enriched environ-

ment, such as a hyperbaric chamber, oxygen tent, etc.
Equipment is not user repairable. Repairs and battery replacement

must be performed by a qualified service representative only.
This equipment/system may cause radio interference or may disrupt

the operation of nearby equipment. It may be necessary to take
mitigation measures, such as reorienting or relocating the
ERO•SCAN® or shielding the location.
CAUTION Use and store the instrument indoors only. It is recommended that
the instrument be operated within an ambient temperature range
of 15 °C to 35 °C / 59 °F to 95 °F and in relative humidity between
30 % and 90 % (non-condensing).
Transport and store the instrument in temperature between 5 °C to

40 °C / 41 °F to 104 °F.
Annual calibration recommended. Have an authorized service

technician perform electrical safety checks on the unit in order to
maintain continued compliance to IEC and UL 60601-1.
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5 Safety Precautions
The following safety precautions must be observed at all times. General safety precautions
must be followed when operating electrical equipment. Failure to observe these precautions
could result in damage to the equipment and injury to the operator or patient.
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
instrument, the more stringent rules should take precedence.
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.
5.1 Cautions - General
CAUTION
If the system is not functioning properly, do not operate it until all
necessary repairs are made and the unit is tested and calibrated for
proper functioning in accordance with MAICO published
specifications.
Use only the disposable eartips designed for use with this
instrument.
Never insert the probe tube into the ear canal without affixing an
eartip.
The eartips are disposable and for single patient use only. Do not
clean or reuse eartips.
Probe tubes are disposable and should be replaced when clogged.

If a probe tube is reused after removal from the probe head, it will
not sit as tight as before.
Do not attempt to clean probe tubes. This may cause damage to

the probe.
Do not drop or otherwise cause undue impact to this device. If the

instrument is dropped or otherwise damaged, return it to the
manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
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5.2 Warning - Electric Shock Hazards

WARNING
Do not open the case of the ERO•SCAN® Instrument. Refer servicing
to qualified personnel.
Do not touch the contacts on the bottom of the instrument and the
patient at the same time.
Do not connect the instrument to the patient and the PC at the same
time.
5.3 Warning - In Case of Emergency

In case of emergency, disconnect the instrument from the supply mains
by removing the micro-USB cable from the connector as shown in Figure
2 on page 20.
5.4 Warning - Explosion
WARNING
This system is not explosion proof. Do not use in the presence of
flammable anesthetics or other gases.
5.5 Warning - Battery Safety
WARNING
This instrument contains a rechargeable lithium-ion battery. The battery
is not user replaceable and must be returned to an authorized MAICO
service location for repair.
5.6 Warning - General

Proper use of this device depends on careful reading of all instructions.
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6 Recycling/Disposal
Many local laws and regulations require special procedures to recycle or dispose of
electrical equipment-related waste including batteries, printed circuit boards,
electronic components, wiring and other elements of electronic devices. Follow all
your respective local laws and regulations for the proper disposal of batteries and
any other parts of this system.
Below is the contact address for proper return or disposal of electronic wastes relating to
MAICO products in North and South America.
MAICO Diagnostics
Tel.: 888.941.4201
Fax: 952.903.4100
WARNING
Batteries may explode or cause burns, if disassembled, crushed or
exposed to fire or high temperatures.
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7 Regulatory Symbols
Symbol IEC Pub. Description
980 & 60601-1 Serial Number
980 & 60601-1 Date of Manufacture
980 & 60601-1 Manufacturer
Caution, Consult Accompanying

980 & 60601-1
Documents
Return to Authorized Representative,

980 & 60601-1
Special Disposal Required
REF 980 & 60601-1 Reference Number
B Patient Applied Part According to

60601-1
IEC60601-1
980 & 60601-1 Consult Operating Instructions
60601-1 Keep Dry
60601-1 Transport and Storage Temperature range
Logo
980 & 60601-1

EU Authorized Representative
Conforms to European Medical Device

980 & 60601-1
Directive 93/42/EEC
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8 Introduction
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. Please see chapter 18 and
19 for further information.
8.1 How Does the ERO•SCAN® Device Work?

Probe Connector The system consists of the instrument,
Test Status
Micro-Probe, single-use eartips,
Indicators replaceable probe tubes, and other
accessories. The ERO•SCAN® instrument
contains the hardware and software for
generating the test stimuli, measuring and
Display displaying the OAEs, and storing the results
until they are printed. The plastic housing
contains circuit boards that provide the
User Interface
Buttons signal processing and display the test
results. The instrument also contains a
Charge Status
Indicator rechargeable lithium-ion battery to power
the device. The instrument uses an organic
light-emitting diode (OLED) display screen
and three light-emitting diodes (LEDs) to
provide a visual display of test status to the
operator. Four membrane-type push
buttons located on the keypad of the
device allow the user to control testing and
printing, and to reset test protocols.
The Micro-Probe houses speaker and

Micro-USB
Connector microphone which produce test stimuli
and measure the sound pressure level (SPL)
present in the sealed ear canal. Interface of
Figure 1 the instrument to the ear canal is
accomplished through disposable eartips,
which fit onto the probe tube. The
disposable eartips are color coded to
facilitate easy selection by size.
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8.2 How are the Results Stored and Reported?

When the ERO•SCAN® is set in its default settings, the instrument will store the results from
one patient (left and right ear) in its non-volatile memory for subsequent printing. However,
the ERO•SCAN® instrument is capable of storing up to 250 test results. The results are
displayed via the OLED on the front of the device and are stored in the device’s internal
memory. After testing is completed, results can be printed using the printer and/or exported
to a computer. Test results are stored in the non-volatile memory so the operator can delay
printing until a later time if desired.
8.3 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 instrument 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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9 Setup
9.1 Unpacking the System
The following is a list of parts shipped with each ERO•SCAN® system:
• ERO•SCAN® Instrument
• Micro-Probe
• Box of Single Use Eartips
• Package of Probe Tubes
• Eartip Removal Tool
• Micro-USB Power Supply for Charging the Lithium-Ion Battery
• Operating Instructions
• PC Database Software with Manual
• Micro B to A USB Cable for PC Communication/Charging
• Protective Carrying Case
Optional:
• Printer
• Printer Power Supply for Charging Printer
• Thermal Printer Paper Roll
If any of these parts are missing, contact your special equipment distributor or MAICO
Diagnostics at 888.941.4201. We recommend that you save the shipping box and packing
materials in case you need to store or ship the system.
9.2 Battery Charging

The ERO•SCAN® instrument is powered by an integrated rechargeable lithium-ion battery
(1800 mAh) providing 15 hours (1000 tests, minimum) of operation between full charging.
The battery status is indicated by the battery icon shown in the upper right corner of the Main
Menu (Display 2, page 23). Full battery charge is represented by a full battery symbol on the
display and reduces to an empty battery in increments corresponding to the discharge of the
battery.
NOTE:
• Battery life will vary depending on each product configuration.
• The maximum capacity of this battery will decrease with time and usage.
• For maximum battery life, do not completely deplete the battery, but charge when 5-10
% of the battery remains.
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The Micro-USB port on the bottom of the instrument is used for

charging via the power supply. Connect the charger as shown in
Figure 2.
NOTE:
NOTE: Misalignment of the plug and socket can cause damage.
The plug and socket should be visually inspected prior to each
Figure 2
installation of the charging cable. If damage is observed, contact
MAICO Diagnostics.
The indicator labeled ‘CHARGE’ (Figure 3) provides a visual

indication (BLUE) of the battery recharging function and battery
status during operation.
Figure 3
During battery charging the indicator will be lit whenever the
Micro-USB connector is engaged and powered. The rate of
illumination of the indicator provides a means of identifying the
status of the charging function, and is defined as follows:
• Steady-state illumination indicates that the battery is fully

charged. This identifies that the charging cycle has been
completed or was not implemented because the battery was
already fully charged.
• Slow blink illumination indicates that the charging function is
in process.
• Fast blink illumination indicates a fault condition in which the
user would be directed by the user manual to return the
instrument for service.
During instrument operation, the user is warned of a low battery
condition by the following illumination of the CHARGE indicator:
• Two fast blinks followed by a pause and then repeated until

the battery is charged.
9.3 Installing the Micro-

Micro-Probe
Turn off the ERO•SCAN® and insert the Micro-Probe connector
into the socket on the top of the ERO•SCAN® (Figure 4). The plug
will fit in only one direction. A MAICO logo is on the probe
connector and will align with the instrument control panel.
NOTE:
NOTE: Misalignment of the plug and socket can cause damage.
The plug and socket should be visually inspected prior to each
Figure 4
installation of the remote probe. If damage is observed, contact
MAICO Diagnostics.
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9.4 Attaching Eartips

The ERO•SCAN® instrument comes with a box of disposable
eartips that fit a variety of ear canal sizes. The probe tube must
have an eartip attached before inserting it into an ear canal. The
determination of the appropriate eartip size should be made by
persons with proper training and experience. The eartip must seal
Figure 5
the ear canal. The best test results are obtained when the eartip
is inserted deeply into the ear canal instead of flush with the ear
canal opening. Caution must be taken, however, to ensure that
the eartip does not extend too deeply into the ear canal. Use only
the eartips approved for use with the instrument. The eartips are
disposable and should be replaced after each patient.
After selecting an eartip, push it onto the probe tube until it is

flush against the base of the probe tube (Figure 5). Twisting the
eartip slightly while pushing it onto the probe is recommended.
Be sure the eartip is fully seated on the probe. There should be
Figure 6
no gaps between the eartip and the collar of the probe head
(Figure 6).
9.5 Removing Eartips

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 7). 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.
Figure 7
NOTE: If the probe tube becomes dirty or clogged, it must be
replaced. See the section 20 Cleaning and Maintenance for
further information.
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10 Operating Instructions
10.1 Preparing the Patient for Testing
Otoscopic examination of the patient’s ear canals should be performed prior to testing.
Excessive cerumen or vernix in the ear canals may interfere with the test and give invalid or
incomplete results. Patients with excessive cerumen, debris, or foreign bodies in the ear canals
should be referred to a qualified professional for removal of the blockage prior to testing.
Place the patient in a position that will allow easy access to the ear canal. Use the shirt clip on
the remote probe to secure the probe to clothing or bedding. The patient should remain still
and quiet while the test is being performed.
10.2 Turning On the Instrument

To turn on the ERO•SCAN® instrument, press the DOWN key
located below the instrument’s display screen (see Figure 8). The
yellow ‘TEST’ light will appear briefly just above the display
screen. The green ‘READY’ light will remain on indicating the
instrument is ready for use. The Flash Screen (Display 1) will
appear briefly. This display will indicate the type of instrument -
Display 1 Screener (SCR), Screener Plus (SC+), Standard (STD), or Combo
(CMB), software version, serial number (for example
ME1234567), and a recalibration date.
If the battery is sufficiently charged, the ERO•SCAN® will power on and automatically check
the date and time. If there are no date/time errors detected, the Main Menu (Display 2, page
23) will appear on the display.
If this is the first time the ERO•SCAN® is being used, or if you wish to change the date or
time, see the section Clock and Date Settings, Chapter 16. If a time/date error message is
indicated, follow the instructions in this section to set the correct date and time.
10.3 Control Panel

The ERO•SCAN® instrument uses 4 buttons to control all
functions of the instrument (Figure 8). These buttons are
arranged in a directional cursor format. The arrows on the
keypad (
LEFT, RIGHT, UP, and DOWN) correspond to the
arrows that are used on the screen. The screen will indicate which
Figure 8 button to push by showing the appropriate arrow.
NOTE: The UP key will always bring the instrument back to
either the previous menu or the main menu. The UP key will
also access the print command from the Main Menu.
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10.4 Main Menu
Selected Protocol
Date & Time Battery Status
Save Mode
and Test #
Start Left Start Right

Ear Test Ear Test
Display 2
Change Protocol
and Settings
10.5 Selecting the Test Protocol

The currently selected protocol is shown on the Main Menu
(Display 2). To change the selected protocol press CHANGE at
the Main Menu. The Change Protocol display will appear (Display
3). Use the CHANGE arrow buttons to change the selected
protocol. Press the UP arrow to return to the Main Menu to
begin testing. Press the SETUP to enter the setup menus.
Display 3 For either DPOAEs or TEOAEs screener devices, there are two
default test protocols that vary by averaging time. Appendix D
contains complete information on protocol settings. For
instructions for customizing diagnostic protocols, review chapter
18 and 19.
NOTE:
NOTE: Screener default protocols cannot be customized.
Diagnostic protocols are customizable.
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10.6 Probe Check (Beginning a Test)

To obtain a seal and measure emissions, gently insert the eartip
into the patient’s ear canal (Figure 9). It should fit snugly and
comfortably. The best test results are obtained when an eartip is
inserted deeply into the ear canal instead of flush with the ear
canal. To begin a test, insert the probe into the ear and select
either the LEFT or RIGHT arrow key to indicate which ear will
Figure 9 be tested.
After the test ear is selected, the Probe Check screen will be
shown. This Probe Check represents the placement of the probe
for two reasons: 1) measure ear canal volume and 2) a seal is
detected. This is reflected by the bar graph displayed. When the
bars are in the orange to the left (Display 4) this represent a very
large ear canal volume or the probe is not inserted into the ear
or in place properly. When the bars are all the way to the right
Display 4 (Display 5), this represent the volume is too small for the test to
begin or probe tip is blocked. Reinsertion and/or inspection of
the probe tip is necessary. When the probe check is anywhere in
the middle area (Display 6), the ear canal volume is in the target
area for testing to begin but will stay grey until the seal is also
detected. Once a seal is established, the grey will turn to green
(Display 7). The test will begin automatically if the probe fit is
stable.
Display 5 Appropriate adjustment of the probe/eartip position and eartip
size selection should be made until the indicator falls within the
green area and remains stable. If the test will not progress past
the Probe Check phase, change the probe tube, check that the
probe connector is fully seated in the socket and try again.
NOTE: Do not remove or insert the probe from the probe

connector unless the device is off.
Display 6
When a seal is obtained, the unit will automatically begin testing

(AutoStart) and the yellow ‘TEST’ LED will illuminate throughout
the test.
NOTE:
NOTE: To test children with PE tubes, the AutoStart needs to be
disabled. This is accomplished by first inserting the probe with
appropriate ear tip into the ear canal and obtaining a proper seal.
To disable AutoStart at the main menu select the ear to be tested
by holding down the LEFT or RIGHT arrow keys for 3 seconds
Display 7
until the green ‘TEST’ light turns off. Once the key is released,
the ERO•SCAN® will calibrate and test as before.
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10.7 Calibration and Test

The ERO•SCAN® instrument will automatically perform a
calibration prior to the start of each test. During calibration a
series of tones will be presented to the ear canal to calibrate the
levels of the frequencies to be tested.
Following calibration of the test tones, the test phase will begin
automatically. During the test phase, a set of bars should appear
Display 8 on the display (Display 8). These are the test results which are
displayed as the emissions are measured and can be reviewed
after the test is complete. Each column represents one test
frequency (DP) or frequency band (TE).
The ERO•SCAN® allows the user to select from two options for
viewing the results. The (SNR) graph view (Display 8) shows the
signal-to-noise ratio for each DP test frequency or TE test band.
The Value graph view (Display 9) shows the absolute emission
Display 9 and noise levels for each DP test frequency or TE test band. For
additional information review the section 13 Interpreting Results
on page 36.
Testing is complete when the green ‘READY’ light is illuminated.

Both the tester and patient should remain as still and quiet as
possible until the green light turns on.
NOTE: The UP arrow key can be used to abort a test in progress.
No record of an aborted test will be saved in memory.
10.8 Viewing Results

When testing is complete, a display similar to Display 10 will
appear. The results of the test are automatically saved in memory
as soon as the test is complete. The results will be saved even if
the unit turns off or the batteries are temporarily depleted. This
screen again indicates the test ear and further gives the results of
the test.
Display 10
• “PASS” on the screen indicates that the patient passed the
screening.
• “REFER” indicates that the patient did not pass the screening.
• “NOISY” indicates that excessive noise was present during
the test.
• “NO SEAL” indicates that a seal was not maintained
throughout the test.
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• “FIT ERR” indicates inadequate probe placement in the ear

canal to produce target stimulus intensities.
When the test result is “NOISY,” “NO SEAL,” or “FIT ERR” the tester should reposition the
probe, selecting a different size eartip if necessary, and retest. If the test result is “REFER” the
tester can determine from the printout whether the test should be repeated. To review the
results, push the DOWN arrow key to return to the graph. After reviewing the results, push
the UP arrow key to return to the Main Menu (Display 2, page 23).
NOTE: Completed tests are automatically saved. By default (Save L/R Mode), the ERO•SCAN®
instrument will save only the last test for each ear. Starting a new test for the same ear will
overwrite the existing test.
NOTE: Once the review screen is exited, results are no longer viewable within the device.
Printing or transferring to the PC is required for continued viewing options.
See the next section Managing Results on page 28 for more information on how the
ERO•SCAN® saves results.
See the section Instrument Settings - Save Mode on page 44 for more information on the
ERO•SCAN® save mode options.
10.9 Test Technique

As with other otoacoustic emission test instruments, there is a technique to learn when using
the ERO•SCAN® instrument, especially while testing infants. Experience with existing OAE
systems suggests that it may take up to 3 months to become completely proficient at
screening infants.
When testing an infant with the ERO•SCAN® instrument, the infant has to be relatively quiet
and calm; it is usually preferred for the infant to be asleep. A pacifier may be used to calm
the infant, however, sucking will add noise to the test and decrease the likelihood of a passing
result. Pull gently down and back on the pinna to straighten out the ear canal. Gently place
the probe tube into the infant’s ear canal.
When testing children and adults, pull gently up and back on the outer ear during insertion
to straighten the ear canal and ensure proper placement.
10.10 Noise Sources

When the noise level exceeds the noise rejection limit of the instrument, the orange ‘NOISE’
light will appear. It is common for the ‘NOISE’ light (See Figure 1, page 17) to appear while
testing. The light will appear infrequently if the noise level in the ear canal is low, and it will
appear more often if the noise level in the ear canal is high. Otoacoustic emissions are very
low-level sounds. Any noise in the ear canal at the time of testing can mask this emission.
This noise can come from a variety of sources.
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The largest source of noise can come from the patient. This is biological noise, such as
movement, coughing, sucking, talking, etc. The patient must be calm and not move or talk.
Ambient noise in the testing environment can also be a large source of noise during the test.
A properly sealed eartip can block a large amount of this noise, but performing the testing in
a relatively quiet environment is recommended.
10.11 TEOAE and Pause Function

The ERO•SCAN® instrument incorporates a pause function within the TEOAE test when a leak
is detected. When the detection occurs, all three LED lights at the top of the device (Noise,
Test and Ready) will illuminate to display the device is in pause mode. The pause mode will
wait for up to 30 seconds. This allows the tester to reposition the probe without starting the
test all over. If the seal is not able to be obtained within the 30 seconds a “No Seal” error
will display and the probe should be repositioned and test restarted.
10.12 Turning Off the Instrument

The ERO•SCAN® instrument has an automatic “shutdown” feature, designed to prolong
battery life. The unit will automatically shut down after 1 minute (default) of inactivity. To
turn it back on, simply press the large DOWN key. This feature can be re-programmed for
various periods of inactivity before “shutdown”. (See the Changing Instrument Settings –
Auto Shutdown Time on page 43.)
NOTE: The UP arrow can be used to manually power off the instrument.
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11 Managing Results
Users have the option of printing to the thermal printer or transferring results to the PC. Each
ERO•SCAN® system will include one or more of these options. Your specific options will vary
depending on the configuration of the system purchased.
11.1 Saving Results

The ERO•SCAN® instrument automatically saves the results of completed tests in the non-
volatile memory (meaning tests are saved even if the battery is temporarily discharged).
However, the ERO•SCAN® is not intended for long-term storage of test results.
NOTE: Users are strongly encouraged to print/transfer all test results at the completion of
testing to avoid potential loss of data.
When operating in the default "Save L/R mode, the ERO•SCAN® instrument will save the
Save L/R"
most recent test results for each ear and print/transfer only these results. This allows the user
to retest a patient after a “REFER” result and to print/transfer only the most recent test result
for each ear. It is recommended that the results be printed after each patient in the default
mode.
When operating in the "Save 250 mode, the ERO•SCAN® will save up to 250 tests. There
Save 250"
are two options in the Save 250 mode:
1. The ERO•SCAN® will automatically number each test from 1 to 250. This allows the
user to save all tests for each patient (tests of the same ear are NOT overwritten) and to
test multiple patients before printing or transferring results. In this mode, it is important
to keep a record of the test number(s) for each patient.
2. The ERO•SCAN® Database Software is used to transfer patient names to the
ERO•SCAN® and the ERO•SCAN® will display the names. When patient names are used
(patient names are uploaded from the ERO•SCAN® Database Software to the
ERO•SCAN® unit) the patient names are displayed on the ERO•SCAN® Unit in
alphabetical order. To move to a different name than the one displayed on the
ERO•SCAN® screen, use the LEFT or RIGHT arrows to cycle through the names until
the desired name is on the display. A patient named “Unnamed” is always included at
the beginning of the ERO•SCAN® list for instances when a patient is being tested but
the patient name was not transferred to the ERO•SCAN®. The “Unnamed” selection
can be used multiple times when transferring to the Database Software.
See Instrument Settings - Save Mode on page 44 for information on changing the save mode
settings.
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11.2 Deleting Results

The ERO•SCAN® holds data in non-volatile memory. The data stays in the memory even after
data is printed by the thermal printer, printed with the Direct-to-Print Software or
downloaded to the ERO•SCAN® Database Software. Data can be deleted through a few
methods, depending on the Save mode.
Save L/R Mode:

• A single test for the Left ear and a single test for the Right ear are held in
memory. Data is deleted when a new test for the left or right ear is started.
NOTE: Following printing or data transfer to the PC software, all tests saved in memory are
marked for deletion and will be permanently deleted when a new test is started. It is not
necessary to manually clear the results.
Save 250 Mode:

• Data is deleted when new Patient Names are uploaded from the Database
Software to the ERO•SCAN® (a warning is provided that data will be
deleted).
• Data can be deleted using the Clear function in the System Menu (page 43).
Data can be deleted in the ERO•SCAN® from the Database Software when the device is
connected to the PC and ERO•SCAN® Database Software is opened. When Names is selected,
the window allows data to be deleted via the Clear Instrument button. See the ERO•SCAN®
Database Software Manual for further instruction.
11.3 Printing to a Thermal Printer
Printer
Printing to an optional thermal printer is by way of wireless
connection. First establish wireless pairing between the
ERO•SCAN® instrument and the printer by following the
instructions in the section Instrument Settings - Wireless Pairing
on page 42.
NOTE: See the printer operating manual for instructions on using

Display 11 the printer or chapter MPT-II SANIBEL Mobile Thermal mini
printer.
Following instructions provided with your printer, be sure the

printer is on and ready for communication/printing. From the
ERO•SCAN® instrument Main Menu (Display 2, page 23 press
the UP button to enter the device connection screen (Display
11). Press the CONNECT button.
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The ERO•SCAN® will search for the paired printer showing

Display 12 while searching. When the printer is found, all the test
results that are stored in memory will print out automatically.
The ERO•SCAN® instrument will power off when printing is

complete.
Display 12 NOTE: All printed test results are marked for deletion, but will
continue to be stored in memory until a new test is started at
which time all tests in the memory will be erased. This allows the
user to reprint the tests if printing is unsuccessful (for example,
the paper runs out before printing is complete).
NOTE: See the ERO•SCAN® Database Software Manual for

instructions on printing from the Database Software or the
Direct-to-Print Software.
11.4 Connecting to the PC Database Software

Connection to the PC database software is achieved by using the provided Micro-USB to
USB-A cable or via wireless connection.
USB Connection:
Plug the correct end (USB-A) of the cable into an available USB port on the computer and
the correct end (Micro-USB) of the cable into the port found on the bottom of the
ERO•SCAN® instrument.
The ERO•SCAN® instrument will detect the connection to the PC and wait for an action or
communication from the PC database software.
Wireless Connection:
Refer to the ERO•SCAN® Database Software Manual for connection via wireless connection.
NOTE: See the ERO•SCAN® Database Software Manual for instructions on using the
application.
11.5 Connecting to the Direct-

Direct-to-
to-Print Software
Connection to the Direct-to-Print Software is achieved by using the provided Micro-USB to
USB-A cable only.
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USB Connection:
Plug the correct end (USB-A) of the cable into an available USB port on the computer and
the correct end (Micro-USB) of the cable into the port found on the bottom of the
ERO•SCAN® instrument.
The ERO•SCAN® instrument will detect the connection to the PC. Printing will immediately
take place, to the printing configuration in the software, once the software is opened.
NOTE: See the ERO•SCAN® Database Software Manual for instructions on using the
application.
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12 MPT-II SANIBEL Mobile thermal mini printer
CAUTION • RISK OF EXPLOSION IF BATTERY IS REPLACED BY AN

INCORRECT TYPE.
• DISPOSE OF USED BATTERIES ACCORDING TO LOCAL
REGULATIONS.
• Do not place the battery in fire or heat the battery.
• Do not connect the positive terminal and the negative
terminal of the battery to each other with any metal
object.
• Do not place the batteries in microwave ovens, high-
pressure containers, or on induction cookware.
• In the event that the battery leaks and the fluid gets into
one’s eye, do not rub the eye. Rinse well with water and
immediately seek medical care. If left untreated the
battery fluid could cause damage to the eye.
• This equipment is for professional use only.
• Do not open the cover while printing. The printer head
might be hot.
• Do not expose the printer to any liquid.
• Do not disassemble the printer.
• If printer is stored for a longer period of time, store the
battery separately.
• For correct battery charging make sure to follow charging
instruction.
General information
MPT-II printer kit includes:

• MPT-II printer
• MPT-II rechargeable battery pack
• Thermal printer paper
• Printer Power supply/charger with plug adapters
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12.1 Operation
Paper loading:
Open the lid by pushing on the sides, insert paper roll as shown,
and close the lid (Figure 10).
Figure 10
NOTE: Reorder paper from MAICO or your local distributor.
Battery pack insertion:
Insert battery as shown (Figure 11).
Figure 11
Power on:
Push POWER BUTTON for two seconds in order to power ON
or OFF.
One short beep will be heard at power ON, two short beeps at
power OFF.
Green Power indicator will be lit if printer is

powered by battery (Figure 12).
Figure 12
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Indicators:
Green LED indicator Blue LED indicator Status Sound Note
Off Fast flash Charging - Power On
Off -
On Charging Power Off
Off Battery nearly -

Slow flash -
discharged
Off Charging
On - Power On
completed
Off Off Charging
- Power Off
completed
On Power ON,
Off - -
battery
powered
Slow flash Slow flash Out of paper Beep -
Slow flash Off Sleep mode - -
Self-
Self-test:
While printer is powered OFF, press and hold PAPER FEED
button, then press and hold POWER BUTTON
simultaneously. When beep is heard after approx. 3 seconds,
release both buttons, and a test page will print with information
on current status and character samples.
Paper feed:
When powered press PAPER FEED button. Paper will feed as
long as the button is pressed.
Wireless setup:
Pairing with the instrument is necessary before printing via
wireless connection is possible.
Pairing process:
Power on printer
• Enter Setup
• Select Wireless Pairing Menu
• Select DISCOVER
• Scroll through paired devices to find printer
• Select PAIR
It is possible to pair up to 8 instruments with one printer. If

more instruments are paired the oldest will be deleted.
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NOTE: Do not have several printers powered on and within

range while searching.
NOTE: See the chapter Wireless Device Pairing for detailed

information.
Technical specifications of Printer:

Printer:
Print mode:
• Thermal line dot print
• Printing width: 48 mm (1.9 in.)
• Resolution: 8 dots/mm (203 dots per
in. (dpi))
• Dots per line: 384 dots
Figure 13
Thermal paper:
• Paper width = 56mm +/- 1 mm (2.2 in.
Physical properties:
+/- 0.04 in.) max. 40 mm (1.6 in.)
• Size: 102 mm x 75 mm x 45 mm (4.02 in.
diameter
x 2.95 in. x 1.77 in.) (W x L x H)
Battery pack: • Weight: 205 g including battery, without
paper
• 2-cell Li-Ion battery pack 7.4 V-1500
mAh
Environmental specifications:
Power supply / charger: • Operational temperature range: -10 °C to
+50 °C (+14 °F to +122 °F)
• 12 V/1 A UE15WCP1-120125SPA
• Operational humidity range: 20 % to
• Maximum current consumption 0.5 A
85 %
(see also Figure 13)
• Storage temperature range: -20 °C to
+70 °C (-4 °F to +158 °F)
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13 Interpreting Results
13.1 Understanding the Display
The display on the ERO•SCAN® test instrument will indicate the results of the test with a
graphic display. The display will be generated and shown during the test and can be reviewed
after the test is complete. The display might differ depending on the settings used for the
test.
Signal-to-Noise Ratio (SNR)
Frequency
**Each column represents an individual frequency
Figure 14
The display above shows a 6-column graph (Figure 14). Each frequency (DPOAEs) or frequency
band (TEOAEs) is indicated by one column.
The ERO•SCAN® allows the user to select from two options for viewing the results. The SNR
graph view shows the signal-to-noise ratio for each DP test frequency or TE test band. The
Value graph view shows the absolute emission and noise levels for each DP test frequency or
TE test band.
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13.2 SNR Graph View

Display 13 shows the SNR bar graph view. These are the signal-
to-noise ratio (SNR) test results which are displayed as the
emissions and noise floor are measured. Each column represents
one DP test frequency or TE frequency band. The height of each
column represents the SNR measured.
When a protocol with a “PASS” criteria has been selected, the

Display 13
user will see a horizontal green line at the decibel level
corresponding to the SNR required for a pass. Green vertical bars
represent a pass, a yellow bar is a non-Pass at the frequency
band.
NOTE: Diagnostic protocols can display green or purple bars.

Green is displayed when a “PASS” criteria is set in the device.
For more information on this see Setting the PASS SNR Level on
page 49.
13.3 Value Graph View
Display 14 shows the Value graph view for right ear. Red circle
symbols represent the absolute emission levels at each DP test
frequency or TE frequency band. For the left ear, dark blue “X”
symbols will represent the absolute emission levels at each DP
test frequency or TE frequency band. White upside-down
triangles (i.e. ) represent the noise floor at each DP test
Display 14 frequency or TE frequency band.
Additional display features include the grey shaded area

representing the Boys Town Norms. This can only be selected for
DPOAE protocols. The green line represents the minimum
amplitude setting has been turned on. Both of these settings are
optional to be displayed and are independent from one another.
These settings are defaulted off.
Refer to page 45 for instructions to switch the default setting of

the graphs between the SNR Bar Graph and Value Graph.
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14 Interpreting Printed Results

Results from the ERO•SCAN® can be printed in multiple ways. It is up to the examiner to
select the appropriate method for their practice needs. The printing options include:
1. Thermal Printout: An optional wireless printer can be purchased for immediate
printing to a thermal printer.
2. Direct- to-Print: The ERO•SCAN® device includes software for the direct to print
Direct-to-
method. Direct-to-Print allows immediate printing to a PDF, default PC printer or
label printer. Review the ERO•SCAN® Database Manual for further information on
this printing method.
3. ERO•SCAN® Database Software:
Software: The ERO•SCAN® device includes database
software. This allows storing of results to a specific patient for review and retrieval,
printing to a PDF or default PC printer.
The information, as specified in section 14.1 and 14.2, is included on the thermal printouts.
For instruction on the other printing options review the Database Software Manual.
14.1 Understanding the DPOAE Printout

The following information is provided for each test (Figure 15):
1) Manufacture Logo
2) The software version number (e.g.: V105.05)
3) The time and date of the test, based on the setting of the
internal clock; if the clock is set correctly, this time and
date will be correct
4) The test number (if operating in “Save 250” mode)
(e.g.:001)
5) The protocol selected (e.g.: DP 2.0 - 5.0)
6) The averaging time used for this test (e.g.: 4 sec avg.)
7) Instrument/Probe serial number (SN)
8) The ear selected (Right or Left)
9) A PASS/REFER indication if there is a criterion set for the
selected protocol
10) Graphic display of results (SNR or Value graph, review
Chapter 13, Interpreting Results for more information)
11) Printout notification when Minimum Amplitude is ‘On’
(e.g.: MIN*)
12) The f2 frequency in kHz (e.g.: 2.0, 3,0, 4.0, 5.0)
Figure 15 13) SPL of presented tones (L1, L2)
14) The level of the emission in dB SPL (DP)
15) The noise floor in dB SPL (NF)
16) The signal-to-noise ratio (SNR) = DP – NF
17) A “P” indicates that the frequency passed based on the
criterion settings within the selected protocol
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14.2 Understanding the TEOAE Printout

The following information is provided for each test (Figure 16):
1) Manufacture Logo
2) The software version number (e.g.: V105.05)
3) The time and date of the test, based on the setting of the
internal clock; if the clock is set correctly, this time and
date will be correct
4) The test number (if operating in “Save 250” mode)
(e.g.:001)
5) The protocol selected (e.g.: TE 64s)
6) The test time used to complete the test (e.g.: 4 sec avg.)
7) Instrument/Probe serial number (SN)
8) The ear selected (Right or Left)
9) A PASS/REFER indication if there is a criterion set for the
selected protocol
10) Graphic display of results (SNR or Value graph, review
Chapter 13, Interpreting Results for more information
11) Printout notification when Minimum Amplitude is ‘on’
12) The frequency band center (F)
Figure 16
13) SPL peak equivalent of presented click (L)
14) The level of the emission in dB SPL (TE)
15) The noise floor in dB SPL (NF)
16) The signal-to-noise ratio (SNR) = TE – NF
17) A “P” indicates that the frequency passed based on the
criterion settings within the selected protocol
NOTE: Figure 15 and Figure 16 display the Value graph on

the printout. The SNR graph display would be as shown in
Figure 17. Review Chapter 13, Interpreting Results for more
information on the graphical display.
Figure 17
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15 Rounding Results
The user needs to be aware that the SNR and single PASS criteria are calculated from the full
internal precision of the instrument, and not from the values shown in the printout for the
emission (TE) and noise floor (NF) estimates.
This approach is used to preserve the full precision of the test results, but can result in some
apparent errors in the printout due to the effects of rounding. In the printout example above,
assume the actual values at 1.5 kHz were TE = 4.5 dB, NF = -0.4 dB, which results in SNR =
4.9 dB. The printout values are rounded up to the nearest integer and are shown as TE = 5,
NF = 0, and SNR = 5. This can result in what appears to be an error with regard to the pass
criterion. If the pass criterion is 5 dB while the actual SNR = 4.9, the printed value will be 5,
but a “P” will NOT be printed.
Again, the pass/refer criterion is based on the full precision of the results, and not the rounded
values that are printed. The full precision value for the SNR must be equal to or greater than
the pass criterion (5 dB in this example) for the “P” to be printed. A similar apparent problem
can occur in which the printed SNR value appears to be incorrect. If the actual values were TE
= 4.5 dB, NF = 0.4 dB, resulting in SNR = 4.1 dB, the printed values would be TE = 5 dB, NF
= 0, SNR = 4. The printed SN value of 4 dB appears to be an error, but is in fact correct.
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16 Clock and Date Settings

When the ERO•SCAN® test instrument is first used, the correct date and time may need to
be set on its internal clock. The date and time are listed on the test printout as day-month-
year (e.g., 07-MAR-14). The clock should be set prior to testing, as changing it after tests are
saved will not change the date on the printout (i.e., whatever date was previously in memory
will be the date on the printout).
Seasonal time changes such as Daylight Saving Time will also require resetting the clock. If
the instrument is being powered on for the first time or if the instrument’s battery is
completely discharged and the battery is not charged within approximately one hour a
“TIME/DATE ERROR” message will occur. If this message appears, reset the time and date.
16.1 Accessing the Clock

Clock Menu
To change the time and date press CHANGE at the main menu
(Display 2, page 23) and then press SETUP at the protocol
selection display (Display 3, page 23). The current date and time
presently set in the unit will be shown (Display 15). If the time
and date are correct, press the UP key to escape back to the
main menu.
Display 15 NOTE: When a Teal arrow is displayed for a DOWN arrow, this
represents an alternative menu is available. To access, hold the
DOWN arrow for 3 seconds until the ‘READY’ light (green LED)
turns off and release the key.
16.2 Changing the Date/Time
If either the date or time is incorrect, press the CHANGE key to

access the menu to change the month (Display 16). Press the
LEFT or RIGHT keys to scroll forward or backward through the
months.
You will see the abbreviated name for each month. When the
Display 16 desired month appears on the display, press the NEXT key to
enter the day selection screen. Pressing the LEFT or RIGHT

keys will scroll through the days of the month. Repeat this
process for the year, hour, and minute using the LEFT or
RIGHT arrow keys to make the selection and the NEXT key to
advance to the next display.
When the correct minute is selected, pressing the DOWN arrow
key (Display 17) will return to the Main Menu. The time and date
Display 17 changes are automatically saved.
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17 Instrument Settings
The ERO•SCAN® instrument allows the user to change many of the instrument's settings or
functions. These settings include Wireless Device Pairing, Clearing Test Results, Auto
Shutdown Time, Minimum Amplitude Value, Save Mode, Clock Mode, Language, and Reset
to Default Settings.
To access the menus to change these functions, press CHANGE at the main menu (Display
2, page 23) and then press SETUP at the Protocol Change (Display 3, page 23) to enter the
Clock menu (Display 17, page 41). At the Clock menu, hold down the CHANGE key for 3
seconds until the ‘READY’ light (green LED) turns off and release the key.
17.1 Wireless Device Pairing – Thermal Printer
The wireless pairing menu (Display 18) allows the user to pair
the ERO•SCAN® unit with a wireless device, such as a thermal
printer or personal computer, for printing test results and data
transfer.
The ERO•SCAN® unit can be paired with only one device at any
time. To establish a wireless pairing, turn on the device that will
Display 18 be paired with the ERO•SCAN® unit (e.g.: thermal printer). Then
select DISCOVER to initiate discovery of available wireless
devices. The ERO•SCAN® will search for available wireless devices
for approximately 15 seconds. During this time the user will see
the message "Please Wait" on the display and the yellow ‘TEST’
LED will flash. Discovery can be canceled by pressing the
CANCEL button.
When discovery is complete, all discovered devices will be shown

Display 19 in the order in which they were found (Display 19). A compatible
thermal printer will appear as "PRT-##-##" (e.g.: PRT-6a-90) and
other devices will be shown by their name which can vary
depending on the device. Use the CHANGE buttons to select
the desired device and then use the PAIR button to pair the
ERO•SCAN® to the selected device.
NOTE: CHANGE will not appear on screen if only one wireless

device is found during the pairing process.
Display 20
Pairing will be confirmed (Display 20). The pairing process is

complete. Select Main Menu to exit the wireless pairing menu.
NOTE: See the Troubleshooting section on page 56 if wireless

pairing is unsuccessful or if any error messages are displayed.
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When pairing to a computer for use with the Database Manager Software, confirm the
computer has wireless connectivity availability or a dongle will be required. Confirm the
wireless settings of the computer (See Figure 18).
Figure 18 Wireless Connection Settings
Select the wireless pairing Menu (Display 18, page 42) and press DISCOVER to start the
pairing process. When the computer is seen on the device, select PAIR. While the device
is pairing to the computer a notification will display on your computer “Add a device“.
Select this notification on your computer and enter PIN 1234. Once paired, the instrument
will show Display 20 on page 42. The first time the ERO•SCAN® Database Manager
Software is opened, select ‘Detect Com Port’ to finalize the ERO•SCAN® connection.
17.2 Clearing Test Results
The Test Results Clear menu (Display 21) allows the user to clear
the test results stored in the unit without printing them. Select
the LEFT or RIGHT arrow key to clear the results and select
Yes or No to verify clearing or to cancel. To advance to the
next menu without clearing the results, press NEXT.
NOTE: Following printing or data transfer to the PC software, all

Display 21
tests saved in memory are marked for deletion and will be
permanently deleted when a new test is started. It is not
necessary to manually clear the results using this menu.
17.3 Auto Shutdown Time

Time
The Power Off menu (Display 22) refers to the Auto Shutdown
time which controls how long the ERO•SCAN® instrument waits
before shutting itself off after a period of inactivity. It is not
necessary to manually turn off the ERO•SCAN® unit. The
Automatic Shutdown feature is designed to prolong the battery
life of the instrument when it is not in use. By default, the
Display 22 instrument automatically shuts off after 1 minute has elapsed.
The Auto Shutdown time may be increased or decreased by

pressing the CHANGE keys. The times available are 30
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seconds, 1, 2, or 4 minutes. Once you have made your selection,

press NEXT.
NOTE: The device will Power Off immediately following a printout

independent of Power Off setting.
17.4 Save Mode/Storing Test Results
The ERO•SCAN® unit automatically stores only the most recent

test result for each ear L/R (Display 23), but has the capacity to
store 250 individual tests. To change the mode to save up to 250
tests, press the LEFT or RIGHT arrow keys to change the menu
to 250. Once you have made your selection, press NEXT.
There are two options in the Save 250 mode (Display 24):
Display 23 1. The ERO•SCAN® will automatically number each test from
1 to 250.
2. The ERO•SCAN® Database Software is used to transfer
patient names to the ERO•SCAN® and the ERO•SCAN®
will display the names. Up to 50 names can be stored in
the device and 250 tests.
When numbers are used (no patient names are uploaded from
the ERO•SCAN® Database Software to the ERO•SCAN®), each
Display 24 test is automatically incremented, starting with test number 1
and displayed in the top left corner of the screen.
NOTE: The main screen (Display 2, page 23) identifies the Save
Mode stored in the device by the representation of 000/002 for
L/R or 000/250 for Save 250 mode.
When patient names are used (patient names are uploaded from the ERO•SCAN® Database
Software to the ERO•SCAN® unit) the patient names are displayed on the ERO•SCAN® Unit
in alphabetical order. To move to a different name than the one displayed on the
ERO•SCAN® screen, use the left or right arrows to cycle through the names until the desired
name is on the display. A patient named “Unnamed” is always included at the beginning
of the ERO•SCAN® list for instances when a patient is being tested but the patient name
was not transferred to the ERO•SCAN®.
It is recommended that you go to the Test Results Clear screen (Display 21, page 43) to clear
any previous memory locations after you changed the Save Mode setting.
NOTE: When using the 250 test mode, it is important to keep a record of the test number
for each patient. When 245 tests have been saved, the user will be warned that the memory
is almost full. When the ERO•SCAN® unit reaches 250 saved tests, it will not allow any
further testing. At this point either the results must be printed, transferred to the PC
software, or they must be cleared from memory.
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17.5 Minimum Amplitude

The Minimum Amplitude setting allows the user to set the unit
to include minimum amplitude values in the pass/refer criterion
(Display 25). The ERO•SCAN® is set with this feature turned OFF
when it is shipped from the factory. If the MIN VALUE is set to
“ON”, a result is not considered a pass unless the amplitude at
each frequency is equal to or greater than the minimum value
programmed into the unit. This is in addition to meeting the
Display 25 other pass criteria including the minimum SNR and the number
of passing frequencies for overall test “Pass”.
To change the mode to Minimum Amplitude setting, press the

LEFT or RIGHT arrow keys to make a selection. Once you have
made your selection, press NEXT.
The minimum DP amplitude when ON is -5 dB SPL.

The minimum TE amplitude selections are -5 and -10 dB SPL.
17.6 Clock Mode

The Clock Mode menu (Display 26) allows the user to change
the clock from a 24 hour mode to a 12 hour mode. To change
the clock mode, press the CHANGE keys. Press the NEXT
to exit this menu.
Display 26
17.7 Graph Style

The Graph Style menu (Display 27) allows the user to select from
two options for viewing the results. The SNR graph view shows
the signal-to-ratio for each DP test frequency or TE test band.
The Value graph view shows the absolute emission and noise
levels for each DP test frequency or TE test band.
See the section Interpreting Results on page 36 for further

Display 27
information.
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17.8 Boys Town Norms

The Norms setting (Display 28) allows the user to show the Boys
Town Norms on the device when in Value Graph mode. This
display will be visible in the Menu selection only if Value Graph
is selected. If SNR Graph is selected, this menu screen will be
hidden as it is not applicable to the SNR graph.
Display 28 NOTE: Norms setting is hidden when TEOAE protocol is selected

as normative data was collected only for DPOAE measurements.
The Boys Town Norms template is explained in the following window. Users should refer to
the reference article for additional information (Figure 19).
Figure 19
17.9 Language
The Language setting (Display 29) allows the user to select
among several languages. To change the language, press the
CHANGE keys until the desired language is shown. Press
NEXT to exit this menu.
Display 29
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17.10 Reset to Default
The Reset to Default menu (Display 30) will return all instrument
settings and protocol settings to their original factory defaults.
Select the LEFT or RIGHT arrow keys to reset and select YES
or NO to verify reset. To exit the System menu without resetting
the instrument, press NEXT to return to the Main Menu.
Display 30
NOTE: This will un-pair the wireless device, clear the test results,
and reset ALL system and protocol settings.
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18 Advanced Options for DPOAE Testing

NOTE: The Advanced Options for DPOAE Testing section is reserved for those units purchased
as a diagnostic device. Instruments purchased as a screener can skip to Section 20.
The Advanced Options menu permit modification of the test parameters and pass criterion
for the customizable DP protocols. Changes to the protocol should be made only by qualified
personnel, usually the administrator. If you are not familiar with the use of these variables, do
not attempt to change the protocols. Changes to any of these characteristics may yield test
results that differ from those obtained in other test modes.
The ERO•SCAN® instrument comes with pre-programmed protocol settings. See Appendix D
for the manufacturer settings of these protocols. Test protocol changes are saved in the non-
volatile memory so the settings will be retained even when the battery is discharged
temporarily.
NOTE: When a change is made within the Advanced Options

menu to a default protocol, an * is place in the protocol name,
see Display 31.
Display 31
18.1 Instructions for Customizing a Test Protocol

To enter the DPOAE Menu:
1) Press CHANGE at the main menu (Display 2, page 23).
2) Using the CHANGE buttons, select the DPOAE protocol you want to
customize (the “DP 4s” protocol is not customizable).
3) Press SETUP at the Protocol menu (Display 3, page 23).
4) At the Clock menu (Display 17, page 41) the teal arrow represents a custom
protocol menu is available. Hold down CHANGE key for 3 seconds until
the ‘READY’ light (green LED) turns off.
5) At the New BT Device menu (Display 8 page 42) the teal arrow represents a
custom protocol menu is available. Hold down the CHANGE key for 3
seconds until the ‘READY’ light (green LED) turns off.
You will now see the Level L1 screen (Display 32, page 49). You are in the DPOAE menu and
will be able to scroll the available protocol parameters with the NEXT button and make
changes by using the LEFT or RIGHT arrow keys to CHANGE the selection.
NOTE: If you push the DOWN arrow key without holding it for 3 seconds, you will scroll
through date and time, etc., rather than accessing the custom protocol menus.
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18.2 Selecting the Level of Primary Tones

The intensity of the primary tones (L1, L2) may be changed to any
level between 40 dB SPL and 70 dB SPL. The level L1 will change
in 1 dB increments by pushing the LEFT or RIGHT arrow keys
(Display 32) and press NEXT to move to the L2 screen.
Press the NEXT key to set the level of L2 as with L1 above.
Display 32
18.3 Setting the Averaging Time

The Averaging Time can be changed to one of four settings. The
Averaging Time will have a large impact on the time required to
perform the test and on the signal-to-noise ratio (SNR). A 2
second average for 6 frequencies would produce a test in about
18 seconds, which includes the Probe Check sequence. The
possible settings for the Averaging Time are as follows:
Display 33 0.5 sec., 1.0 sec., 2.0 sec., or 4.0 sec.
Press the CHANGE

keys to select an option and the NEXT
key to exit.
NOTE: Longer averaging times help to reduce the noise floor

which can improve the likelihood of obtaining a passing result,
particularly with a noisy patient (like a baby sucking a pacifier) or
in a noisy environment. However, shorter averaging times may
be preferred for young children and/or uncooperative patients.
18.4 Setting the PASS SNR Level

In order to provide a PASS/REFER determination for each test, the
PASS SNR must be set. This number refers to the number of
decibels that the DPOAE signal must be above the noise to be
considered a PASS at that frequency. The limits for the PASS SNR
are 3 dB to 10 dB. Pressing the LEFT or RIGHT arrow keys will
increase or decrease the requirement. This requirement is used in
combination with the number of frequencies (discussed below)
Display 34 to determine an overall PASS/REFER for each test.
Press the CHANGE keys to select an option and the NEXT

key to exit (Display 34).
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18.5 Setting the Number of Frequencies for PASS

The number of frequencies required for determining a PASS can
be set from 0 to 12. If the setting is on 0, then no indication of
PASS/REFER will be made. This setting is used in conjunction with
the PASS SNR (Display 35) to set the criteria for the overall test
PASS/REFER indication. For example, if the PASS SNR is set to 5
dB and the number of frequencies for PASS is set to 3, then the
test must contain at least 3 frequencies where the emission is at
Display 35
least 5 dB above the noise to indicate a PASS.
The number of frequencies for PASS should also be based on the

number of frequencies being tested. Setting the number of
frequencies for PASS to 5 when only 4 frequencies are being
tested would result in every test being labeled as a REFER.
NOTE: To disable the PASS/REFER indication set the number of

frequencies for pass to 0.
NOTE:
NOTE: Diagnostic protocols display the SNR graph with purple
bars. Once the “Number of Frequencies for PASS” is set above
zero, green bars display to identify this setting.

key to exit Display 35.
18.6 Reset Protocol
Selecting the RESET arrow key in the Reset Protocol menu

(Display 36) will return the selected protocol settings to their
original factory settings. Press the NEXT key to exit.
NOTE:
NOTE This does not affect the instrument settings or the settings
Display 36 of any other protocol.
18.7 Save Protocol
Once all of the settings have been selected for the protocol, these
settings can be saved by selecting the SAVE keys (Display 37).
Press the DONE key to exit.
Selection of the DONE before saving will not save the selection
Display 37
made to the protocol.
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19 Advanced Options for TEOAE Testing

NOTE: The Advanced Options for TEOAE Testing section is reserved for those units purchased
as a diagnostic device. Instruments purchased as a screener can skip to Section 20.
The Advanced Options menu permits modification of the test stimuli and measurement values
for the TE Custom Protocol. Changes to the protocol should be made only by qualified
personnel, usually the administrator. If you are not familiar with the use of these variables, do
not attempt to change the protocols. Changes to any of these characteristics may yield test
results that differ from those obtained in other test modes.
The ERO•SCAN® instrument comes with pre-programmed protocol settings. See Appendix D
for the manufacturer settings of these protocols. Test protocol changes are saved in the non-
volatile memory so the settings will be retained even when the battery is discharged
temporarily.
NOTE: When a change is made within the Advanced Options

menu to a default protocol, an * is place in the protocol name,
see Display 38.
Display 38
19.1 Instructions for Customizing a Test Protocol

To enter the TEOAE Menu:
1) Press CHANGE at the main menu (Display 2, page 23).
2) Using the CHANGE buttons, select the TEOAE protocol you want to
customize (the "TE 64s" protocol is not customizable).
3) Press SETUP at the Protocol menu (Display 3, page 23)
4) At the Clock menu (Display 17, page 41) the teal arrow represents a
custom protocol. Hold down the CHANGE key for 3 seconds until the
‘READY’ light (green LED) turns off.
5) At the New BT Device menu (Display18, page 42) the teal arrow
represents a custom protocol menu is available. Hold down the
CHANGE key for 3 seconds until the ‘READY’ light (green LED) turns off.
You will now see the Averaging Time screen (Display 39, page 52). You are in the TEOAE
menu and will be able to scroll the available protocol parameters with the NEXT button
and make changes by using the LEFT or RIGHT arrow keys to CHANGE the selection.
NOTE: If you push the DOWN arrow key without holding it for 3 seconds, you will scroll
through date and time, etc., rather than accessing the custom menus.
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19.2 Selecting the Averaging Time

The Averaging Time can be changed to one of five settings. The
Averaging Time will have a significant impact on the time
required to perform the test and on the signal-to-noise ratio
(SNR). A 4 second average would produce a test in about 4
seconds. A 32 second average would produce a test in about 32
seconds. This timing does not reflect the Probe Check process.
Display 39 The possible settings for the Averaging Time are as follows:
4, 8, 16, 32 or 64 seconds.
The instrument will automatically stop the test when the pass
criterion is met prior to the averaging time. Press the
CHANGE keys to select an option and the NEXT key to exit
(Display 39).
19.3 Setting the PASS SNR Level

In order to provide a PASS/REFER determination for each test, the
PASS SNR must be set. This number refers to the number of
decibels that the TEOAE signal must be above the noise to be
considered a PASS at that frequency. The limits for the PASS SNR
are 3 dB to 10 dB. Pressing the LEFT or RIGHT arrow keys will
increase or decrease the requirement. This requirement is used in
Display 40
combination with the number of frequencies (discussed below)
to determine an overall PASS/REFER for each test.

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19.4 Setting the Number of

of Frequencies for PASS
The number of frequencies for determining a PASS can be set
from 0 to 6. If the setting is on 0, then no indication of
PASS/REFER will be made. This setting is used in conjunction with
the PASS SNR to set the criteria for the overall test PASS/REFER
indication. For example, if the PASS SNR is set to 4 dB and the
number of frequencies for PASS is set to 3 then the test must
Display 41 contain at least 3 frequencies where the emission is at least 4 dB
above the noise to indicate a PASS.

NOTE: Diagnostic protocols display the SNR graph with purple

bars. Once the “Number of Frequencies for PASS” is set above
zero, green bars display to identify this setting.
19.5 Reset Protocol

Selecting the RESET arrow key in the Reset Protocol menu
(Display 42) will return the selected protocol settings to their
original factory settings. Press the NEXT key to exit.
NOTE:
NOTE This does not affect the instrument settings or the settings
Display 42 of any other protocol.
19.6 Save Protocol

Once all of the settings have been selected for the protocol, these
settings can be saved by selecting the SAVE keys (Display 43).
Press the DONE key to exit.
Selection of DONE before saving will not save the selections

made to the protocol.
Display 43
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20 Cleaning and Maintenance

20.1 Cleaning and Disinfection
Use a new eartip for each patient. Eartips are for single patient use only. The probe tube,
which does not make direct contact with the patient, should be replaced if there is any sign
of contamination or if the test will not progress past the Probe Check phase. Disinfection of
the probe tube between patients is not required.
External parts of the instrument/probe can be cleaned to remove visible particulate

contamination. Do not attempt to insert any object into probe.
This instrument is not designated as a ‘sterile’ device. Wiping with a clean cloth or towel and
a mild non alcohol-based disinfecting solution, provides a suitable form of cleaning and low-
level disinfection of the housing and probe exterior. Repeat this weekly, or as often as
conditions warrant, to prevent a build-up of grime from normal handling and use.
We believe low-level disinfection is appropriate for this type of instrument. This may not
conform to the infection control guidelines of the user’s facility. The disinfection materials
and procedures applied in the users’ facility may be more appropriate for their circumstances
than the methods outlined above (see cautions below). The frequency of cleaning and
disinfecting is dependent on the facility’s risk assessment, usage, and test environment.
CAUTION
• Do not immerse the instrument or probe in fluids or
attempt to sterilize the instrument or any of its
accessories.
• Do not allow any fluid to enter the device.
• Do not use autoclave sterilization.
• Do not use alcohol-based disinfectants.
• Take care not to put excessive pressure on the clear
display window or allow any utensil to puncture the
display window or control panel.
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.
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20.2 Maintenance
This instrument requires no regular maintenance beyond routine cleaning and annual
calibration. The probe tube requires replacement only when it becomes clogged.
A defective product should not 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.
Equipment is not user repairable. Repairs and battery replacement must be performed by a
qualified service representative only.
Annual calibration is recommended. Have an authorized service technician perform electrical

safety checks on the unit in order to maintain continued compliance to IEC and UL 60601-1.
20.3 Probe Tube

Tube Replacement
Probe tubes are disposable and should be replaced when they become clogged. A package
of replacement probe tubes is included with this instrument. Do not attempt to clean the
probe tube.
To replace the probe tube, use the eartip to grasp the probe tube
(the clear plastic tube) and twist slightly while pulling the probe tube
straight out of the probe head (Figure 20).
Figure 20
Dispose of the used probe tube immediately to avoid confusing

used tubes and new tubes. Take a new probe tube from the
package and insert the tube into the probe head until it is fully
seated (Figure 21). A properly inserted probe tube will snap
securely into place when it is fully seated in the probe head.
Figure 21 NOTE: If the probe tube is re-used after it was removed from the
probe head once it will not sit as tight as before.
CAUTION DO NOT ATTEMPT TO CLEAN PROBE TUBES. THIS MAY CAUSE

DAMAGE TO THE PROBE.
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21 Troubleshooting
Problem Solutions
Instrument does • The DOWN arrow must be pressed for a full second (the
not turn on Yellow ‘TEST’ LED will illuminate).
• Connect the charger as shown in Figure 2 on page 20. Confirm
that the blue "Charging" LED is illuminating in a slow blink
pattern. Wait at least 10 minutes and then attempt to turn on
the instrument
• Contact MAICO for service if the problem persists.
The test will not • Select a different sized eartip.
start • Reposition the probe.
• Change the probe tube.
• Verify that the eartip is sealed in the ear canal via feedback
from the PROBE CHECK screen.
• Check that the instrument will start in your own ear with the
proper eartip for testing yourself. If the test will not start or if
the AutoStart tones sound unusual, replace the probe tube.
• Contact MAICO for service if the problem persists across
several patients.
The results will not • Check the printer status. Turn the printer on (wake from sleep
print mode) by pressing the large button.
• If the printer does not turn on, plug in the power supply to
charge the battery.
• Be sure the printer has paper.
• If paper comes out of the printer but there is no text on the
paper then the paper is in backwards.
• Press the large printer button twice rapidly to run demo print.
Display is frozen • Press and hold the DOWN arrow button for 10 seconds to
and instrument force the instrument to power off. Powering the instrument
will not respond to back on again should reset/restore normal function.
button presses • Contact MAICO for service if the problem persists.
Numerical results • Dashes are displayed when there is excessive noise during that
show a line rather test frequency. Reduce the noise and retest.
than a number
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Message Solutions
Attach • Probe not detected. Check that the probe connector is fully
Probe seated in the socket.
• Disconnect and reconnect the probe.
• Cycle instrument power.
BT Device • Paired to Printer:
Not Found o Check that the printer is turned on.
o Move closer to the printer.
o Recycle printer’s power (press Power button until all
lights are off, then press Power for steady green).
o Try again.
• Paired to PC Computer or wireless connectivity dongle:
o Check that the serial port is open. Establishing the serial
port is handled by the PC and/or the software, not by
the ERO•SCAN® instrument.
BT Error • Check BT device (printer or PC) status.
#xxx • Attempt to connect to BT device again.
• Contact MAICO if the problem persists.
BT Not • Printing has been attempted, but no BT device is paired with
Configured the ERO•SCAN® Instrument. Establish wireless pairing.
Device Not • The printer is not responding to queries from the instrument.
Responding Check printer status.
• Awaken printer from sleep mode.
• Charge printer battery if necessary.
Due for Service • Indicates calibration of instrument is recommended. Message
will appear upon the calibration due date set in the device.
Message appears during device startup once per day.
Fit Error • For a DP test, the desired level (L1 or L2) cannot be obtained
Cannot Obtain L within allowable limits. User should refit the probe and retry
the test.
• Replace the probe tube.
several patients.
Fit Error • For a DP test, the level of the calibration tone is too high. User
Too High should refit the probe and retry the test.
several patients.
Fit Error • For a DP test, the level of the calibration tone is too low. User
Too Low should refit the probe and retry the test.
several patients.
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Message Solutions
Limit • Overflow error during the calculation of the DFTs for a DP test.
Error User should repeat the test.
• Cycle instrument power.
Memory almost full • Saved tests are within 5 tests of the maximum limit. Print or
transfer test result to avoid interruption in testing.
Memory Full! • The maximum saved test limit is reached. The user will need to
clear the memory before any additional tests can be
performed.
Power Low! • The battery charge level is too low for operation. The user must
charge the battery before additional tests can be performed.
Printer Error • Indicates a problem with the printer. Check the printer status.
• Reset the printer or cycle the printer power.
Printer Paper Out! • Replace the paper roll.
Time/Date Error • The clock is checked during power on to ensure it has not lost
time and been reset. In the case of clock reset, this message is
shown. The user should set the correct date/time.
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22 Specifications
MICRO-
MICRO-PROBE SPECIFICATIONS
Measurement Type: Distortion Product Otoacoustic Emissions (DPOAE)

Transient Evoked Otoacoustic Emissions (TEOAE)
Frequency Range: Screener version:

DPOAE: 2.0 kHz to 5.0 kHz
TEOAE: 1.5 kHz to 4.0 kHz
Diagnostic version:
DPOAE: 1.5 kHz to 12.0 kHz
TEOAE: 0.7 kHz to 4.0 kHz
Stimulus Intensity Range: DPOAE: 40 dB SPL to 70 dB SPL

TEOAE: 83 dB SPL peak equivalent (±3 dB)
Microphone System Noise: -20 dB SPL at 2 kHz (1 Hz bandwidth) / -13 dB SPL at 1

kHz (1 Hz bandwidth)
Dimensions and Weight: Length: 1.0 meter (40 in.)

Weight: 28 g (1.00 oz.)
Connector: HDMI
INSTRUMENT SPECIFICATIONS
Power Supply: Lithium-Ion rechargeable
Battery Life: 1000 tests per charge, minimum

15 hours on-time
Dimensions and Weight: Dimensions: W X D X H 2.58 X 1.23 X 5.78 in.

Instrument Weight: 180 g (6.4 oz.)
User Interface: OLED display to provide user information and progress

of measurement
4-button keypad to control instrument functions
Connectors / Communications: Integrated USB communication capability for battery

charging and communication with PC-based database
programs or an optional printer
HDMI Connector for connection to the Micro-Probe
Integrated wireless Class 2 + EDR with SPP Protocol for
communication with optional printer
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POWER SUPPLY SPECIFICATIONS (use only approved power supply)
Model No: UE08WCP-050160SPA

Output: 5.0 V DC, 1.6 A
Input 100 V-240 V AC, 50 Hz - 60 Hz, 400 mA
ENVIRONMENTAL REQUIREMENTS
Operating Temperature: 15 ° C to 35 ° C / 59 ° F to 95 ° F
Operating Relative Humidity: 30 % to 90 % (non-condensing)
Maximum Operating Altitude: 2000 meters (6000 feet)
Transport and Storage 5 ° C to 40 ° C / 41 ° F to 104 ° F

Temperature:
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Appendix A: Flowcharts
A.1 Test Operation Flowchart
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A.2 Setup Menu Flowchart

Flowchart
NOTE DPOAE Menu and TEOAE Menu are not accessible in the ERO•SCAN® Screening
NOTE:
version.
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Appendix B: Test Sequence

A complete test sequence consists of a Probe Check, calibration, and test phase. The Probe
Check phase determines when the calibration phase should proceed, while the calibration
phase calibrates the level of the tones that will be applied during the actual test phase. Artifact
rejection is employed during the test phase to reduce the effect of transient noise bursts.
Immediately after the test button is pressed, the Probe Check phase of the test begins. Probe
Check phase checks both the quality and stability of the seal by measuring the response
obtained from a sequence of test tones. The stability of the seal is determined by comparing
the responses obtained over time. When the level of the response is within an acceptable
range and is stable over time, the unit proceeds to the calibration phase.
FOR DPOAE
The calibration phase automatically measures the response obtained from a sequence of
calibration tones and calculates the voltage needed to obtain the desired pressures. If the
desired peak pressure cannot be obtained, the unit will use the maximum voltage. A
successful calibration leads to the actual test phase.
The test phase consists of measuring the response obtained from the pairs of test frequencies
(f1, f2) applied to the receivers. Two receivers are used, with each receiver generating one
frequency in order to reduce intermodulation distortion. Frequency domain estimates of the
actual L1, L2, distortion (DP) and noise floor (NF) are obtained via the discrete Fourier
Transform, with a bin resolution of approximately 31 Hz. The NF estimate is obtained by
averaging the power in the 4 closest (+/-2) bins to the DP bin.
FOR TEOAE
The calibration phase automatically measures the peak pressure obtained from a sequence of
clicks and calculates the voltage required to obtain the target peak pressure. If the desired
peak pressure cannot be obtained, the unit will use the maximum voltage.
The test phase consists of measuring the response obtained from repeated sequences of clicks
applied to the receivers. The click sequence is 3-1-1-1 repeated twice. Signal and noise floor
estimates are obtained by adding/subtracting the two response sequences, respectively. The
energy of the signal and noise floor estimates in various frequency bands is obtained in real
time and displayed once per second. The average peak pressure of the stimulus is calculated
after completion of the test.
Artifact rejection is employed during the test phase to reduce the effect of transient noise
bursts by the use of an adaptive rejection threshold. The unit attempts to accept the quieter
sections of the test, while rejecting the noisier portions of the test. When the noise level is
approximately constant during the test, the instrument will tend to accept most of the data
in the test. However, as the level of the noise becomes more variable over time, the instrument
will attempt to accept the quieter portions of the recording. Noise estimates are obtained
approximately 32 times per second and a suitable threshold is estimated from the data. Data
segments with a noise floor above this threshold are rejected, which tends to lower the noise
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floor of the test. In order to reduce the possibility of obtaining an artificially low noise floor,
the minimum threshold level is limited.
Comment about Variations in the SNR Estimate

The user needs to be aware that the SNR estimate has an inherent statistical variation due to
the effects of random noise, especially when no emission is actually present. If a test is
performed with the instrument’s probe placed in a test cavity, it can be shown theoretically
that the SNR will be greater than 6 dB approximately 7 times out of 100. This is not a limitation
of the instrument, but a fundamental property of the method used to estimate the SNR in all
emission testing. In order to reduce the occurrence of this “false” emission, the instrument
limits the minimum value of NF, which has the effect of reducing the SNR for tests that have
a low noise floor. As the noise level of the test increases, the user will notice that more “false”
emissions will appear, which is to be expected.
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Appendix C: Pass/Refer Criteria

Pass/Refer Criteria for DPOAE
The decision that a DPOAE exists is based on detecting a signal whose level is significantly
above the background noise level. This requires a statistical decision, since the random noise
level in the DPOAE filter channel can be expected to exceed the average of the random noise
levels in the four adjacent filter channels — used as the reference for comparison — roughly
half the time.
Extended measurements of the noise distributions in both the DPOAE filter channel “DP
level” and the rms average of the 4 adjacent channels “N level” indicate that the signal-to-
noise ratio (the difference between DP and N) has a standard deviation of 5.5 dB. As shown
in Diagram 1 (page 66), this implies a 10 % probability of seeing a 7 dB SNR simply from
the variability of the noise levels in the 2 filter sets.
Requiring an SNR of 6 dB in three out of four frequencies drops the probability of passing an
ear with significant hearing loss to 1 % or less.
NOTE:
NOTE: By the binomial distribution, two of three frequencies at >8.4 dB or three of six
frequencies at >7 dB should also ensure less than 1 % probability of passing a moderately-
severe hearing-impaired infant.
Preliminary ERO•SCAN® trials with infants indicate that the tester’s technique is the single
most important variable in the pass rate on normal-hearing infants. Some testers pick up the
technique (see Operating Instructions section, page 22) with only a couple of day’s practice,
producing pass rates comparable to those for other DPOAE equipment they have used for
months; other testers take longer.
Occasional claims of extraordinarily low probabilities of missing an ear with hearing loss
appear to be based on poor statistics. As discussed by Gorga (Mayo Clinic Teleconference,
1998), since the incidence of significant hearing loss is roughly 2 per 1,000, verifying a 99.7
% accuracy would require testing hundreds of thousands of babies with a given system. Thus
to demonstrate that only 3 babies out of 1,000 with hearing loss were missed would require
follow-up testing on 500,000 babies. To our knowledge, no one has performed such tests to
date.
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Diagram 1
Pass/Refer Criteria for TEOAE

The same basic principles that underlie DPOAE Pass/Fail criteria underlie TEOAE Pass/Fail
criteria. In the case of transients, requiring SNR of 4 dB at any three out of the six test
frequencies drops the probability of passing an ear with a significant hearing loss to less than
1 %.
NOTE:
NOTE The SNR limits for transients are lower than the corresponding limits for distortion
products primarily because the traditional noise calculation used in TEOAE measurements (and
in the ERO•SCAN® instrument) gives a 3 dB lower SNR than the calculation used for DPOAEs.
Without that difference, the numerical SNR value for a PASS with the two methods would be
quite similar.
The ERO•SCAN® uses a novel noise-rejection algorithm (patent pending) that permits
accurate DPOAE and TEOAE measurements in background noise and babble as high as 55 dB
SPL to 65 dB SPL (A-weighted). Briefly explained, use of available memory in the ERO•SCAN®
processor permits a post-hoc statistical analysis that identifies those samples whose retention
would improve the overall accuracy. Those samples are included in the final analysis; the
noisier samples are rejected.
The improved operation in noise with the new algorithm was so substantial that we
conducted a complete replica of our original validation tests in "fully impaired ear" cavities
and were able to verify that no increase in false negatives (false passes) was introduced. Under
no test conditions was any such degradation uncovered.
The artifact rejection can only reject the noisiest samples in a measurement period. If the
ambient noise level rises too high (and/or the eartip seal is poor), then all samples will be noisy
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and accurate measurements will be impossible, in which case the test result will indicate
“noisy”.
Diagram 2
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Appendix D: Configurations and Test Protocols

DPOAE Protocols
#
Passing
# of F2 Freq. Averaging Freq. for
Name Freq. [kHz] L1/L2 Time Pass SNR Test Pass
Screening DP 4s 4 2, 3, 4, 5 65/55 4 sec 6 dB 3
DP 2s 4 2, 3, 4, 5 65/55 2 sec 6 dB 3
Diagnostic DP 2.0- 4 2, 3, 4, 5 65/55** 4 sec** 6 dB** 3**
5.0
DP 1.5- 6 1.5, 2, 3, 4, 65/55** 4 sec.** 6 dB** 0**
6.0 5, 6
DP 1.6- 12 1.6, 2, 2.5, 65/55** 4 sec.** 6 dB** 0**
8.0 3.2, 3.6, 4,
4.5, 5, 5.6,
6.3, 7.1, 8
DP 1.5- 12 1.5, 2, 3, 4, 65/55** 4 sec.** 6 dB** 0**
12 5, 6, 7, 8, 9,
10, 11, 12
(Diagnostic version also includes DP 4s screening protocol)
TEOAE Protocols
#
# of Passing
Freq. Freq. center Averaging Time Freq. for
Name Bands bands [kHz] (max) Pass SNR Test Pass
Screening TE 64s 6 1.5, 2, 2.5, 3, 64 4 dB 3
3.5, 4
TE 32s 6 1.5, 2, 2.5, 3, 32 4 dB 3
3.5, 4
Diagnostic TE1.5- 6 1.5, 2, 2.5, 3, 64 sec** 4 dB** 3**
4.0 3.5, 4
TE0.7- 6 0.7, 1, 1.4, 2, 64 sec.** 4 dB** 0**
4.0 2.8, 4
(Diagnostic version also includes TE 64s screening protocol)
** Customizable fields:
L1/L2: DP: 40 to 70 dB SPL
Average time: DP: 0.5, 1.0, 2.0 or 4.0 sec, TE 4, 8, 16, 32 or 64 sec.
Pass SNR: DP and TE: 3 dB to 10 dB
Passing Freq. for Test Pass: DP and TE: 1 to 12
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Appendix E: EMC Compatibility

Portable and Mobile RF communications equipment can affect the ERO•SCAN®. Install and operate
the ERO•SCAN® according to the EMC information presented on this page and the next 4 pages.
The ERO•SCAN® has been tested for EMC emissions and immunity as a standalone instrument. Do
not use the ERO•SCAN® adjacent to or stacked with other electronic equipment. If adjacent or
stacked use is necessary, the user should verify normal operation in the configuration.
The use of accessories, transducers and cables other than those specified, with the exception of
servicing parts sold by MAICO Diagnostics as replacement parts for internal components, may result
in increased EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional
equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard.
Electromagnetic Compatibility
Although the instrument fulfills the relevant EMC requirements precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g. from mobile phones, etc. If the device is used
adjacent to other equipment it must be observed that no mutual disturbance appears.
Electrical Safety, EMC and Associated Standards

1. UL 60601-1: Medical Electrical Equipment, Part 1 General
Requirements for basic safety and essential performance
2. IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General

Requirements for basic safety and essential performance
3. CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1

General Requirements for Safety Electrical Equipment for Laboratory
Use
4. IEC/EN 60601-1-2: Medical Electrical Equipment, Part 1 -

Electromagnetic Compatibility - Requirements and Tests
5. Essential Requirements of the current European Union Medical Device

Directive 93/42/EEC
6. RoHS (Restriction of the use of certain Hazardous Substance)
7. WEEE (Waste Electrical & Electronic Equipment) Legislation
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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The ERO•SCAN® is intended for use in the electromagnetic environment specified below. The customer or
the user of the ERO•SCAN® should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - Guidance
RF Emissions Group 1 The ERO•SCAN® uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions Class B Limits The ERO•SCAN® is suitable for use in all
CISPR 11 commercial, industrial, business, hospital, and
Harmonic Emissions Class A Category residential environments.
IEC 61000-3-2
Voltage Fluctuations / Complies
Flicker Emissions
IEC 61000-3-3
Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and the ERO•SCAN®
The ERO•SCAN® is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the ERO•SCAN® can help prevent electromagnetic interferences
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the ERO•SCAN® as recommended below, according to the maximum output power of
the communications equipment.
Rated Maximum Separation distance according to frequency of transmitter
Output Power of m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter
d = 1.17√ d = 1.17√ d = 2.23√
W
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitters, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1:1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Electromagnetic
Environment-Guidance
Electrostatic Discharge ±6 kV contact ±6 kV contact Floors should be wood,
(ESD) concrete or ceramic tile.
±8 kV air ±8 kV air If floors are covered with
IEC 61000-
61000-4-2 synthetic material the
relative humidity should
be greater than 30%.
Electrical Fast ±2 kV for power supply ±2 kV for power supply Mains power quality
Transient/Burst lines lines should be that of a
±1 kV for input/output ±1 kV for input/output typical commercial,
IEC 61000-
61000-4-4 lines lines hospital, or residential
environment.
Surge ±1 kV differential mode ±1 kV differential mode Mains power quality
should be that of a
IEC 61000-
61000-4-5 ±2 kV common mode ±2 kV common mode typical commercial,
hospital, or residential
environment.
Voltage Dips, Short <5 % UT <5 % UT Mains power quality
Interruptions and (>95 % dip in UT) for (>95 % dip in UT) for should be that of a
Voltage Variations on 0.5 cycle 0.5 cycle typical commercial,
Power Supply Lines 40 % UT 40 % UT hospital, or residential
(60% dip in UT) for 5 (60% dip in UT) for 5 environment. If the user
IEC 61000-
61000-4-11 cycles cycles of the ERO•SCAN®
70 % UT 70 % UT requires continued
(30% dip in UT) for 25 (30% dip in UT) for 25 operation during power
cycles cycles mains interruptions, it is
5 % UT 5 % UT recommended that the
(>95% dip in UT) for 5 (>95% dip in UT) for 5 ERO•SCAN® be powered
sec sec from an uninterrupted
power supply.
Power Frequency (50/60 3 A/m 3 A/m Power frequency
Hz) magnetic fields should be
at levels characteristic of
IEC 61000-
61000-4-8 a typical location in a
typical commercial or
hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Test Compliance Electromagnetic Environment-
Environment-Guidance
Level
Portable and mobile RF communications
Conducted RF 3 Vrms 150 kHz 3 Vrms equipment should be used no closer to any part
IEC 61000-4-6 to 80 MHz of the ERO•SCAN®, including cables than the
recommended separation distance calculated
Radiated RF 3 V/m 80 MHz to 3 V/m from the equation applicable to the frequency of
IEC 61000-4-3 2.5 GHz the transmitter.
Recommended separation distance
d = 1.17√
d = 1.17√ 80 MHz to 800 MHz
d = 1.17√ 800 MHz to 2.5 GHz
where P is the maximum output power rating of

the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field Strengthens from fixed RF transmitters, as
determined by an electromagnetic site survey
(a*), should be less than the compliance level in
each frequency range (b*).
Interference may occur in the vicinity of
equipment marked:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
(a*) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the ERO•SCAN® is used
exceeds the applicable RF compliance level above, the ERO•SCAN® should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the ERO•SCAN®.
(b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Specifications are subject to change without notice
MAICO Diagnostics
Tel.: 888.941.4201
Fax: 952.903.4100
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8106286-3_EROSCAN_US_15i.docx 74 11/15

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Operation Manual

10.6 Probe Check (Beginning a Test) .................................................. 24

17.10 Reset to Default ......................................................................... 47

Title: ERO•SCAN® Screening and Diagnostic Version – Operation Manual

MAICO Diagnostics is an ISO 13485 certified corporation.

ANSI/ASA 3.6 2010 Specification for Audiometers

ISO 14971 2007 Application of Risk Management to Medical Devices

ISO 10993 2009 Biological Evaluation of Medical Devices

EN 60601-1-2 2007 Medical electrical equipment -- Part 1-2: General

FCC Part 15 FCC 47CFR, Part 15..247 & 15.249

IEC 60601-1 2005 Clause 8.9.1.8; Pollution Degree Classification: 2

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,

2.1 Intended Use

2.2 Indications for Use

3 Warnings, Cautions and Errors

WARNING The WARNING label identifies conditions or practices that may

CAUTION The CAUTION label identifies conditions or practices that could

WARNING The ERO•SCAN® Otoacoustic Emission Test System should be

No modifications of the equipment are allowed by anyone other

The ERO•SCAN® product has been verified by an independent

This icon indicates that patient applied parts of the instrument

Instruments which bear the Underwriters Laboratories, Inc. label

Any program aimed at obtaining reliable measurements of

This device complies with part 15 of the FCC Rules. Operation is

3.1 Status/Error Messages

Attach Probe No probe is detected at the start of a test.

Indicator LEDs (lights):

Do NOT use in the presence of flammable gaseous mixtures. Users

Do NOT use the ERO•SCAN® in a highly oxygen-enriched environ-

Equipment is not user repairable. Repairs and battery replacement

This equipment/system may cause radio interference or may disrupt

Transport and store the instrument in temperature between 5 °C to

Annual calibration recommended. Have an authorized service

5.1 Cautions - General

Probe tubes are disposable and should be replaced when clogged.

Do not attempt to clean probe tubes. This may cause damage to

Do not drop or otherwise cause undue impact to this device. If the

5.2 Warning - Electric Shock Hazards

5.3 Warning - In Case of Emergency

5.4 Warning - Explosion

5.5 Warning - Battery Safety

5.6 Warning - General

980 & 60601-1 Serial Number

980 & 60601-1 Date of Manufacture

980 & 60601-1 Manufacturer

Caution, Consult Accompanying

Return to Authorized Representative,

REF 980 & 60601-1 Reference Number

B Patient Applied Part According to

980 & 60601-1 Consult Operating Instructions

60601-1 Keep Dry

60601-1 Transport and Storage Temperature range

980 & 60601-1

Conforms to European Medical Device

8.1 How Does the ERO•SCAN® Device Work?

The Micro-Probe houses speaker and

8.2 How are the Results Stored and Reported?

8.3 Sensitivity and Specificity

9.2 Battery Charging