ERO•SCAN® Operating Instruction

ERO•SCAN® Operating Instruction
Maico Diagnostics
Operating Instruction
ERO•SCAN®
MAICO Diagnostic •7625 Golden Triangle Drive • Eden Prairie, MN • 55344 • Tel: 888-941-4201 • Fax: 952-903-4100
ERO•SCAN® Operating Instruction
Table of Contents
1
Standards Compliance ............................................................................. 1
2
Warranty .................................................................................................. 2
2.1
3
Intended Use ........................................................................................................................................3
Warnings, Cautions, and Errors .............................................................. 4
3.1
Status/Error Messages .........................................................................................................................5
4
Customer Responsibility .......................................................................... 6
5
Safety Precautions ................................................................................... 7
5.1
Cautions - General................................................................................................................................7
5.2
Warning - Electric Shock Hazards.........................................................................................................8
5.3
Warning - In Case of Emergency ..........................................................................................................8
5.4
Warning - Explosion .............................................................................................................................8
5.5
Warning - Battery Safety ......................................................................................................................8
5.6
Warning - General ................................................................................................................................8
6
Recycling/Disposal ................................................................................... 9
7
Regulatory Symbols............................................................................... 10
8
Introduction ........................................................................................... 12
9
8.1
How Does the ERO•SCAN® Device Work?......................................................................................... 12
8.2
How are the Results Stored and Reported? ..................................................................................... 13
8.3
Sensitivity and Specificity .................................................................................................................. 13
Setup ...................................................................................................... 14
9.1
Unpacking the System....................................................................................................................... 14
9.2
Battery Charging ............................................................................................................................... 14
9.3
Installing the Micro-Probe ................................................................................................................ 15
9.4
Attaching Eartips ............................................................................................................................... 16
10 Operating Instructions .......................................................................... 17
10.1
Preparing the Patient for Testing ...................................................................................................... 17
10.2
Turning On the Instrument ............................................................................................................... 17
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10.3
Control Panel..................................................................................................................................... 18
10.4
Main Menu........................................................................................................................................ 18
10.5
Selecting the Test Protocol ............................................................................................................... 19
10.6
AutoStart (Beginning a Test) ............................................................................................................. 19
10.7
Calibration and Test .......................................................................................................................... 20
10.8
Viewing Results ................................................................................................................................. 21
10.9
Test Technique .................................................................................................................................. 22
10.10
Noise Sources ................................................................................................................................ 22
10.11
Turning Off the Instrument ........................................................................................................... 22
11 Managing Results .................................................................................. 23
11.1
Saving Results.................................................................................................................................... 23
11.2
Printing to a Thermal Printer ............................................................................................................ 23
11.3
Connecting to the PC Database Software ......................................................................................... 24
12 MPT-II SANIBEL Mobile thermal mini printer ....................................... 25
12.1
Operation .......................................................................................................................................... 26
13 Interpreting Results ............................................................................... 29
13.1
Understanding the Display................................................................................................................ 29
13.2
Understanding the DPOAE Printout.................................................................................................. 30
13.3
Understanding the TEOAE Printout .................................................................................................. 30
14 Rounding Results ................................................................................... 31
15 Clock Settings ........................................................................................ 32
15.1
Accessing the clock menu ................................................................................................................. 32
15.2
Changing the Date/Time ................................................................................................................... 32
16 Instrument Settings ............................................................................... 33
16.1
Bluetooth® Device Pairing ................................................................................................................. 33
16.2
Clearing Test Results ......................................................................................................................... 34
16.3
Auto Shutdown Time ........................................................................................................................ 34
16.4
Save Mode/Storing Test Results ....................................................................................................... 34
16.5
Minimum Amplitude ......................................................................................................................... 35
16.6
Clock Mode ....................................................................................................................................... 35
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16.7
Language ........................................................................................................................................... 35
16.8
Reset to Default ................................................................................................................................ 36
17 Advanced Options for DPOAE Testing ................................................. 37
17.1
Instructions for Customizing a Test Protocol .................................................................................... 37
17.2
Selecting the Level of Primary Tones ................................................................................................ 38
17.3
Setting the Averaging Time ............................................................................................................... 38
17.4
Setting the PASS SNR Level ............................................................................................................... 38
17.5
Setting the Number of Frequencies for PASS ................................................................................... 39
17.6
Reset Protocol ................................................................................................................................... 39
17.7
Save Protocol .................................................................................................................................... 39
18 Advanced Options for TEOAE Testing .................................................. 40
18.1
Instructions for Customizing a Test Protocol .................................................................................... 40
18.2
Selecting the Averaging Time............................................................................................................ 41
18.3
Setting the PASS SNR Level ............................................................................................................... 41
18.4
Setting the Number of Frequencies for PASS ................................................................................... 41
18.5
Reset Protocol ................................................................................................................................... 42
18.6
Save Protocol .................................................................................................................................... 42
19 Cleaning and Maintenance ................................................................... 43
19.1
Cleaning and Disinfection ................................................................................................................. 43
19.2
Maintenance ..................................................................................................................................... 44
19.3
Probe Tube Replacement.................................................................................................................. 44
20 Troubleshooting .................................................................................... 45
21 Specifications ......................................................................................... 48
Appendix A: Flowcharts .............................................................................. 50
Appendix B: Test Sequence ........................................................................ 52
Appendix C: Pass/Refer Criteria .................................................................. 54
Appendix D: Configurations and Test Protocols........................................ 57
Appendix E: EMC Compatibility ................................................................. 58
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Title: ERO•SCAN® OAE Instrument – Operating Instructions
MAICO Diagnostic
7625 Golden Triangle Drive
Eden Prairie, MN 55344
Tel.: 888.941.4201
Fax: 952.278.4481
E-mail: [email protected]
Internet: www.maico-diagnostics.com
EC REP
MAICO Diagnostic GmbH
Salzufer 13/14
10587 Berlin
Germany
Tel.: +49 30 – 70 71 46 50
Fax: +49 30 – 70 71 46 99
E-mail: [email protected]
Internet: www.maico.biz
Copyright © 2014 MAICO Diagnostic. 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 Diagnostic is an ISO 13485 certified corporation.
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1 Standards Compliance
Standard
Issue
Date
Title
ANSI/ASA 3.6
2010
Specification for Audiometers
IEC 60601-1
2007
IEC 60645-1
2004
Medical Electrical Equipment – General Requirements for
Basic Safety and Essential Performance, Ed. 3
Electroacoustics – Audiological equipment – Part 1: Puretone 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 47CFR, Part 15.247 & 15.249 (Bluetooth®)
FCC Part 15
UL 60601-1
2005
Clause 8.9.1.8; Pollution Degree Classification: 2
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2 Warranty
MAICO Diagnostic 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 Diagnostic shall void this warranty.
MAICO Diagnostic 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 Diagnostic by phone at 888.941.4201 or by fax at
952.903.4100.
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2.1 Intended Use
The ERO•SCAN® OAE Test Instrument is indicated for testing of cochlear function in infants,
children, and adults by measuring otoacoustic emissions (OAEs). This instrument is suitable for
use in all settings, including hospitals, schools, physician's offices, and audiologist practices.
Factory defined protocols allow for simple screening measurements and user customizable
protocols allow for diagnostic evaluations.
The ERO•SCAN® is intended to be used by hearing healthcare professionals (i.e. ENT doctors,
audiologists) and/or technicians, neonatal nurses and school nurses who have been trained by a
hearing healthcare professional.
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.
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3 Warnings, Cautions, and Errors
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 twoprong 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.
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.
This icon indicates that patient applied parts of the instrument
conform to IEC 60601-1:2005, Type B requirements.
Any program aimed at obtaining reliable measurements of
otoacoustic emissions should be staffed and supervised by
appropriately-trained individuals.
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3.1 Status/Error Messages
Display Messages:
Attach Probe
BT Device Not
Found
BT Error #xxx
BT Not
Configured
Device not
Responding
Due For Service
Fit Error
Cannot Obtain L
Fit Error
Too High
Fit Error
Too Low
Limit Error
Memory Almost
Full
Memory Full!
Power Low!
Printer Error
Printer Paper
Out!
Time/Date Error
No probe is detected at the start of a test.
The paired Bluetooth® device cannot be detected. The device may be turned
off or too far away.
There is an error condition with the Bluetooth® device. Check the status.
The ERO•SCAN® instrument is not paired with any Bluetooth® device.
The printer is not responding to queries from the instrument.
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.
For a DP test, the desired level (L1 or L2) cannot be obtained within allowable
limits. User should refit the probe and retry the test.
For a DP test, the level of the calibration tone is too high. User should refit the
probe and retry the test.
For a DP test, the level of the calibration tone is too low. User should refit the
probe and retry the test.
Overflow error during the calculation of the DFTs for a DP test. User should
repeat the test.
Saved tests are within 5 tests of the maximum limit.
The maximum saved test limit is reached. The user will need to clear the
memory before any additional tests can be performed.
The battery charge level is too low for operation. The user must charge the
battery before additional tests can be performed.
Indicates a problem with the printer. Check the printer status.
Indicates that printer paper has run out.
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.
Indicator LEDs (lights):
The indicator labeled ‘NOISE’ provides a visual indication (AMBER) that the
NOISE / Orange
TEST / Yellow
READY / Green
CHARGE / Blue
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.
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.
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.
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 environment, 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.
CAUTION
Use and store the instrument indoors only. It is recommended that
the instrument be operated within an ambient temperature range
of 15 °C / 59 °F to 35 °C / 95 °F and in relative humidity between
30% and 90% (non-condensing).
Transport and store the instrument in temperature between +5 °C /
+4 °F 1 to +40 °C / +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.
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 connected 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 14.
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 Diagnostic
7625 Golden Triangle Drive
Eden Prairie, MN 55344
Tel.: 888.941.4201
Fax: 952.278.4481
E-mail: [email protected]
Internet: www.maico-diagnostics.com
WARNING
Batteries may explode or cause burns, if disassembled, crushed or exposed
to fire or high temperatures.
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7 Regulatory Symbols
No.
Symbol
REF
IEC Pub.
Description
980 & 60601-1
Serial Number
980 & 60601-1
Date of Manufacture
980 & 60601-1
Manufacturer
980 & 60601-1
Caution, Consult Accompanying
Documents
980 & 60601-1
Return to Authorized Representative,
Special Disposal Required
980 & 60601-1
Reference Number
60601-1
980 & 60601-1
B Patient Applied Part According to
IEC60601-1
Consult Operating Instructions
60601-1
Keep Dry
60601-1
Transport and Storage Temperature
range
Logo
EC REP
980 & 60601-1
980 & 60601-1
10
EU Authorized Representative
Conforms to European Medical Device
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 Screening or Diagnostic version. Please see chapter 17 and 18
for further information.
8.1 How Does the ERO•SCAN® Device Work?
Probe Connector
Test Status
Indicators
Display
User Interface
Buttons
Charge Status
Indicator
Micro-USB
Connector
Figure 1
The system consists of the instrument, MicroProbe, printer, single-use eartips, replaceable
probe tubes, and other accessories. The
ERO•SCAN®
instrument
contains
the
hardware and software for generating the
test stimuli, measuring and displaying the
OAEs, and storing the results until they are
printed. The plastic housing contains circuit
boards that provide the signal processing and
display the test results. The instrument also
contains a rechargeable lithium-ion battery to
power the device. The instrument uses a
liquid-crystal display (LCD) and three lightemitting 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
microphone which produce test stimuli and
measure the sound pressure level (SPL)
present in the sealed ear canal. Interface of
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 LCD 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
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
Diagnostic 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
Figure 2
The ERO•SCAN® instrument is powered by an integrated
rechargeable lithium-ion battery (1800 mAh) providing 20 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). 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: Misalignment of the plug and socket can cause damage. The plug and socket should be
visually inspected prior to each installation of the charging cable. If damage is observed,
contact MAICO Diagnostics.
The indicator labeled ‘CHARGE’ provides a visual indication (BLUE) of the battery recharging
function and battery status during operation.
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-Probe
Turn off the ERO•SCAN® and insert the Micro-Probe connector
into the socket on the top of the ERO•SCAN® (Figure 3). The plug
will fit in only one direction. The MAICO logo will align with the
instrument control panel.
Figure 3
NOTE: Misalignment of the plug and socket can cause damage.
The plug and socket should be visually inspected prior to each
installation of the remote probe. If damage is observed, contact
MAICO Diagnostic.
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9.4 Attaching Eartips
Figure 4
Figure 5
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
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 4). 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 no
gaps between the eartip and the collar of the probe head (Figure
5).
To remove the eartip, grasp the eartip at the base and twist it while
pulling it straight off the end of 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.
NOTE: If the probe tube becomes dirty or clogged, it must be
replaced. See the section Probe Tube Replacement 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
Display 1
To turn on the ERO•SCAN® instrument, press the DOWN key
located below the instrument’s display screen (see Figure 6). The
yellow 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 - Screener (SCR), Screener Plus
(SC+), Standard (STD), or Combo (CMB), software version, and
serial number (for example ME1234567).
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) 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 Settings on page
32. If a time/date error message is indicated, follow the instructions
in this section to set the correct date and time.
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10.3 Control Panel
The ERO•SCAN® instrument uses 4 buttons to control all functions
of the instrument (Figure 6). 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 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.
Figure 6
10.4 Main Menu
Selected Protocol
Battery Status
Time
Start Left
Ear Test
Start Right
Ear Test
Display 2
Change Protocol
and Settings
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ERO•SCAN® Operating Instruction
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.
NOTE: Screener default protocols
Diagnostic protocols are customizable.
10.6
cannot
be
customized.
AutoStart (Beginning a Test)
Figure 7
Display 4
Display 5
To obtain a seal and measure emissions, gently insert the eartip into
the patient’s ear canal. 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 be tested.
After the test ear is selected, the AutoStart screen (Display 4) will be
shown. This display shows two horizontal bar graphs representing the
environmental noise (NOISE) and the ear canal volume (VOLUME).
When both bars fill the screen from left to right, the environmental
noise is high and the ear canal volume is large.
The NOISE and VOLUME bar readings should be used as an indication
that the unit is sealing the ear canal:
 If the VOLUME and NOISE bars are filling the screen, the eartip is
not sealing the ear canal. Select a different size and reposition
the eartip.
 If the NOISE bar is filling the screen (VOLUME bar is reduced), the
patient may be too noisy or the probe fit is unstable (moving too
much). Reduce patient noise by swaddling a baby, distracting a
child, and reinstructing an adult.
 If the VOLUME bar is filling the screen (NOISE bar is reduced), the
patient may have a PE tube or eardrum perforation. Try bypassing
AutoStart (see note on page 20).
 If the VOLUME bar is not visible at all, the eartip may be blocked
by cerumen (wax) or vernix or is resting against the wall of the
ear canal. Refit the eartip and/or change the eartip/probe tube as
necessary. Appropriate adjustments should be made until a
decrease in these bars is seen.
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ERO•SCAN® Operating Instruction
For an adult, the VOLUME bar will decrease to about half (Display
5). For an infant or child, the VOLUME bar will decrease further to
the left (Display 6). The NOISE bar will show a decrease from the
original reading. When a seal is obtained, the unit will
automatically begin testing (AutoStart) and the yellow test LED will
illuminate throughout the test.
Display 6
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
until the green “test” light turns off. Once the key is released, the
ERO•SCAN® will calibrate and test as before.
10.7 Calibration and Test
The ERO•SCAN® instrument will automatically perform a
calibration at the start of each test (Display 7). During calibration a
series of tones will be presented to the ear canal to calibrate the
levels of the frequencies to be tested.
Display 7
Display 8
Following calibration of the test tones, the test phase will begin
automatically. During the test phase, a set of bars should appear
on the display (Display 8). These are the test results which are
displayed as the emissions are measured. Each column represents
one test frequency (DP) or frequency band (TE). Each row
represents 2 dB of signal-to-noise ratio measured at each of the
test frequencies or in each of the frequency bands. Additional
information is available in the section Interpreting Results on page
29.
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.
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ERO•SCAN® Operating Instruction
10.8 Viewing Results
When testing is complete, a display similar to Display 9 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 9
“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.
“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 bar graphs (Display 9). After reviewing
the results, again push the DOWN arrow key to return to the Main Menu (Display 2).
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.
See the next section Managing Results on page 23 for more information on how the
ERO•SCAN® saves results and how to print or transfer those results to the PC database
software.
See the section Instrument Settings - Save Mode on page 34 for more information on the
ERO•SCAN® save mode options.
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ERO•SCAN® Operating Instruction
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 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.
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 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 34.)
NOTE: The UP arrow can be used to manually power off the instrument.
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ERO•SCAN® Operating Instruction
11 Managing Results
Users have the option of printing to the thermal printer or transferring results to the
ERO•SCAN® PC Database. 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 nonvolatile 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
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 with each
test being numbered 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.
See Instrument Settings - Save Mode on page 34 for information on changing the save mode
settings.
11.2 Printing to a Thermal Printer
Printing to an optional thermal printer is by way of Bluetooth®
connection. First establish Bluetooth® pairing between the
ERO•SCAN® instrument and the printer by following the
instructions in the section Instrument Settings - Bluetooth® Device
Pairing on page 33.
Display 10
NOTE: See the printer operating manual for instructions on using
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), press the
23
8105730 Rev B
ERO•SCAN® Operating Instruction
UP button to enter the device connection screen (Display 10). Press the CONNECT
button.
The ERO•SCAN® will search for the paired printer showing Display
11 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 11
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).
11.3 Connecting to the PC Database Software
Connection to the PC database software is achieved by using the provided Micro-USB to USB-A
cable.
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.
NOTE: See the ERO•SCAN® Database Software Manual for instructions on using the
application.
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8105730 Rev B
ERO•SCAN® Operating Instruction
12 MPT-II SANIBEL Mobile thermal mini printer
Cautions












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, highpressure 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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8105730 Rev B
ERO•SCAN® Operating Instruction
12.1 Operation
Paper loading:
Open the lid by pushing on the sides, insert paper roll as shown,
and close the lid (Figure 8).
Figure 8
NOTE: Reorder paper from Maico or your local distributor.
Battery pack insertion:
Insert battery as shown (Figure 9).
Figure 9
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 10).
Figure 10
26
8105730 Rev B
ERO•SCAN® Operating Instruction
Indicators:
Green LED indicator
Blue LED indicator
Status
Sound
Note
Off
Fast flash
Charging
-
Power On
Off
On
Charging
Off
Slow flash
Off
On
Off
Off
On
Off
Slow flash
Slow flash
Battery nearly
discharged
Charging
completed
Charging
completed
Power ON,
battery
powered
Out of paper
Slow flash
Off
Sleep mode
-
Power Off
-
-
Power On
-
Power Off
-
-
Beep
-
-
-
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
long as the button is pressed.
button. Paper will feed as
Bluetooth® setup:
Pairing with the instrument is necessary before printing via
Bluetooth® is possible.
Pairing process:
Power on printer




Let the instrument / PC search for other Bluetooth® devices.
A device called MPT-II should occur in the list of devices.
When prompted enter password “1234.”
Finish pairing.
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8105730 Rev B
ERO•SCAN® Operating Instruction
NOTE: Do not have several printers powered on and within range
while searching.
It is possible to pair up to 8 instruments with one printer. If more
instruments are paired the oldest will be deleted.
For detailed instructions how to initiate Bluetooth® search, please
refer to your device’s user manual.
NOTE: See the chapter Bluetooth® Device Pairing for more detailed
information.
Technical specifications
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 11
Physical properties:
 Size: 102 mm x 75 mm x 45 mm (4.02
in. x 2.95 in. x 1.77 in.) (W x L x H)
 Weight: 205 g including battery,
without paper
Thermal paper:
 Paper width = 56mm +/- 1 mm (2.2 in.
+/- 0.04 in.) max. 40 mm (1.6 in.)
diameter
Battery pack:
 2-cell Li-Ion battery pack 7.4 V-1500
mAh


Power supply / charger:
 12 V/1 A UE15WCP1-120125SPA
 Maximum current consumption 0.5 A
See also Figure 11

28
Environmental specifications:
Operational temperature range: -10 °C
to +50 °C (+14 °F to +122 °F)
Operational humidity range: 20 % to 85
%
Storage temperature range: -20 °C to
+70 °C (-4 °F to +158 °F)
8105730 Rev B
ERO•SCAN® Operating Instruction
13 Interpreting Results
13.1 Understanding the Display
Signal-to-Noise Ratio (SNR)
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.
Each vertical
segment represents
2 dB SNR
Frequency
Each column represents
an individual frequency
Figure 12
The display shows a 6-column graph (Figure 12). Each frequency (DPOAEs) or frequency band
(TEOAEs) is indicated by one column. Each row represents 2 dB of signal-to-noise ratio (SNR).
For example, if the column goes to the top of the display then the SNR is 12 dB or greater (6
rows of 2 dB each).
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ERO•SCAN® Operating Instruction
13.2 Understanding the DPOAE Printout
The following information is provided for each test (Figure 13):
Figure 13
1) The software version number (e.g.: V100.01)
2) 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
3) The test number (if operating in “Save 250” mode)
(e.g.:001)
4) The protocol selected (e.g.: DP 4s)
5) The averaging time used for this test (e.g.: 4 sec avg.)
6) Instrument/Probe serial number (SN)
7) The ear selected (Right or Left)
8) A PASS/REFER indication if there is a criterion set for the
selected protocol
9) The open blocks indicate the noise floor in dB SPL
10) The solid blocks indicate the emission level in dB SPL
11) The f2 frequency in kHz (e.g.: 2.0, 3,0, 4.0, 5.0)
12) The level of the emission in dB SPL (DP)
13) The noise floor in dB SPL (NF)
14) The signal-to-noise ratio (SNR) = DP – NF
13.3 Understanding the TEOAE Printout
The following information is provided for each test (Figure 14):
Figure 14
1) The software version number (e.g.: V100.01)
2) 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
3) The test number (if operating in “Save 250” mode)
(e.g.:001)
4) The protocol selected (e.g.: TE 32s)
5) The averaging time used for this test (e.g.: 10 sec avg.)
6) Instrument/Probe serial number (SN)
7) The ear selected (Right or Left)
8) A PASS/REFER indication if there is a criterion set for the
selected protocol
9) The open blocks indicate the noise floor in dB SPL
10) The solid blocks indicate the emission level in dB SPL
11) The frequency band center (F)
12) The level of the emission in dB SPL (TE)
13) The noise floor in dB SPL (NF)
14) The signal-to-noise ratio (SNR) = TE – NF
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ERO•SCAN® Operating Instruction
14 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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ERO•SCAN® Operating Instruction
15 Clock Settings
Display 12
When the ERO•SCAN® test instrument is first used, the correct
date and time will need to be set on its internal clock. The date and
time are listed on the test printout as month-day-year (e.g., Feb28-12). 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, Display 12 may
appear. If this message appears, reset the time and date.
15.1 Accessing the clock menu
To change the time and date press CHANGE at the main menu
(Display 2) and then press SETUP at the protocol selection display
(Display 3). The current date and time presently set in the unit will
be shown (Display 13). If the time and date are correct, press the
UP key to escape back to the main menu.
Display 13
15.2 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 14). Press the
LEFT or RIGHT keys to scroll forward or backward through the
months.
Display 14
Display 15
You will see the abbreviated name for each month (Display 14).
When the 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. After the
correct day is selected, press the NEXT key to enter the day
selection display. Again use the LEFT or RIGHT arrow keys to
set the correct day. 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 15) will return to the Main Menu.
The time and date changes are automatically saved.
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ERO•SCAN® Operating Instruction
16 Instrument Settings
The ERO•SCAN® instrument allows the user to change many of the instrument's settings or
functions. These settings include Bluetooth® 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)
and then press SETUP at the Protocol Change (Display 3) to enter the Clock menu (Display
13). At the Clock menu, hold down the CHANGE key for 3 seconds until the Ready light
(green LED) turns off and release the key.
NOTE: Releasing the key will access the menus to change the instrument settings.
16.1 Bluetooth® Device Pairing
The Bluetooth® pairing menu (Display 16) allows the user to pair
the ERO•SCAN® unit with a Bluetooth® device, such as a thermal
printer or personal computer, for printing test results and data
transfer.
Display 16
Display 17
Display 18
The ERO•SCAN® unit can be paired with only one device at any
time. To establish Bluetooth® pairing, turn on the device that will
be paired with the ERO•SCAN® unit (e.g.: thermal printer). Then
select DISCOVER to initiate discovery of available Bluetooth®
devices. The ERO•SCAN® will search for available Bluetooth®
devices for approximately 15 seconds. During this time the user will
see the message "Please Wait" on the display and the yellow LED
will flash. Discovery can be canceled by pressing the CANCEL
button.
When discovery is complete, all discovered devices will be shown in
the order in which they were found (Display 17). A compatible
thermal printer will appear as "PRT-##-##" (example: PRT-00-df)
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.
Pairing will be confirmed (Display 18). The pairing process is
complete. Select Main Menu to exit the Bluetooth® pairing
menu.
NOTE: See the Troubleshooting section on page 45 if Bluetooth®
pairing is unsuccessful or if any error messages are displayed.
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ERO•SCAN® Operating Instruction
16.2 Clearing Test Results
The Test Results Clear menu (Display 19) 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.
Display 19
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 using this menu.
16.3 Auto Shutdown Time
Display 20
The Power Off menu (Display 20) 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 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
seconds, 1, 2, or 4 minutes. Once you have made your selection,
press NEXT.
16.4 Save Mode/Storing Test Results
The ERO•SCAN® unit automatically stores only the most recent test
result for each ear L/R (Display 21), 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.
Display 21
It is recommended that you go to the Test Results Clear screen
(Display 19) to clear any previous memory test results 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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ERO•SCAN® Operating Instruction
16.5 Minimum Amplitude
Display 22
The Minimum Amplitude setting allows the user to set the unit to
include minimum amplitude values in the pass/refer criterion
(Display 22). 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 other pass criteria including the
minimum SNR and the number of passing frequencies for overall
test “Pass.” The ERO•SCAN® is set with this feature turned OFF
when it is shipped from the factory.
To change the mode to Minimum Amplitude setting, press the LEFT or RIGHT arrow keys
to select ON or OFF. Once you have made your selection, press NEXT.
The minimum DP amplitude is -5 dB SPL.
The minimum TE amplitude is -10 dB SPL.
16.6 Clock Mode
The Clock Mode menu (Display 23) 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 23
16.7 Language
The Language setting (Display 24) 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 24
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16.8 Reset to Default
The Reset to Default menu (Display 25) 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 25
NOTE: This will unpair the Bluetooth® device, clear the test results,
and reset ALL system and protocol settings.
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17 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 19.
The Advanced Options menus 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 nonvolatile memory so the settings will be retained even when the battery is discharged
temporarily.
17.1 Instructions for Customizing a Test Protocol
To enter the DPOAE Menu:
1) Press CHANGE at the main menu (Display 2).
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).
4) At the Clock menu (Display 13) hold down the CHANGE
key for 3 seconds until the Ready light (green LED) turns
off.
5) At the New BT Device menu (Display 16) 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 26). 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 displays that allow you to make changes
to the custom protocols.
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17.2 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 and
press NEXT to move to the L2 screen (Display 26).
Press the NEXT key to set the level of L2 as with L1 above
(Display 26).
Display 26
17.3 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 0.5
second average for 6 frequencies would produce a test in about 4
seconds. A 2 second average for 6 frequencies would produce a
test in about 14 seconds. The possible settings for the Averaging
Time are as follows:
Display 27
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 (Display 27).
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.
17.4 Setting the PASS SNR Level
Display 28
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) to
determine an overall PASS/REFER for each test.
Press the CHANGE keys to select an option and the NEXT key to exit (Display 28).
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17.5 Setting the Number of Frequencies for PASS
Display 29
The number of frequencies required 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 (Display 28) 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 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.
Press the CHANGE keys to select an option and the NEXT key to exit (Display 29).
17.6 Reset Protocol
Selecting the RESET arrow key in the Reset Protocol menu
(Display 30) will return the selected protocol settings to their
original factory settings. Press the NEXT key to exit.
Display 30
NOTE: This does not affect the instrument settings or the settings
of any other protocol.
17.7 Save Protocol
Once all of the settings have been selected for the protocol, these
settings can be saved by selecting the SAVE keys (Display 31).
Press the DONE key to exit.
Display 31
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18 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 19.
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 nonvolatile memory so the settings will be retained even when changing the batteries.
18.1 Instructions for Customizing a Test Protocol
To enter the TEOAE Menu:
1) Press CHANGE at the main menu (Display 2).
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)
4) At the Clock menu (Display 13) hold down the CHANGE
key for 3 seconds until the Ready light (green LED) turns
off.
5) At the New BT Device menu (Display 16) 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 32). 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 displays that allow you to make changes
to the custom protocols.
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18.2 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 7 seconds. A
16 second average would produce a test in about 18 seconds. The
possible settings for the Averaging Time are as follows:
Display 32
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 32).
18.3 Setting the PASS SNR Level
Display 33
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
combination with the number of frequencies (discussed below) to
determine an overall PASS/REFER for each test.
Press the CHANGE keys to select an option and the NEXT
key to exit (Display 33).
18.4 Setting the Number of Frequencies for PASS
Display 34
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 contain at least
3 frequencies where the emission is at least 4 dB above the noise
to indicate a PASS.
Press the CHANGE keys to select an option and the NEXT
key to exit (Display 34).
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18.5 Reset Protocol
Selecting the RESET arrow key in the Reset Protocol menu
(Display 35) will return the selected protocol settings to their
original factory settings. Press the NEXT key to exit.
Display 35
NOTE: This does not affect the instrument settings or the settings
of any other protocol.
18.6 Save Protocol
Once all of the settings have been selected for the protocol, these
settings can be saved by selecting the SAVE keys (Display 36).
Press the DONE key to exit.
Display 36
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19 Cleaning and Maintenance
19.1 Cleaning and Disinfection
Use a new eartips 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 AutoStart 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.
Important:
• 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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19.2 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.
19.3 Probe 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 15).
Figure 15
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 16). A properly inserted probe tube will snap
securely into place when it is fully seated in the probe head.
Figure 16
CAUTION
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.
DO NOT ATTEMPT TO CLEAN PROBE TUBES. THIS MAY CAUSE
DAMAGE TO THE PROBE.
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20 Troubleshooting
Problem
Instrument does
not turn on
The test will not
start
The results will not
print
Display is frozen
and instrument will
not respond to
button presses
Solutions
 The DOWN arrow must be pressed for a full second (the Yellow
LED will illuminate).
 Connect the charger as shown in Figure 2 on page 14. 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.
 Select a different sized eartip.
 Reposition the probe.
 Change the probe tube.
 Verify that the eartip is sealed in the ear canal via feedback from
the NOISE and VOLUME bars during AUTOSTART.
 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.
 Check the printer status. Turn the printer on (wake from sleep
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.
 Contact MAICO for service if the problem persists.
 Press and hold the DOWN arrow button for 10 seconds to force
the instrument to power off. Powering the instrument back on
again should reset/restore normal function.
 Contact MAICO for service if the problem persists.
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Message
Attach
Probe
BT Device
Not Found
BT Error
#xxx
BT Not
Configured
Device Not
Responding
Due for Service
Fit Error
Cannot Obtain L
Fit Error
Too High
Fit Error
Too Low
Solutions
 Probe not detected. Check that the probe connector is fully
seated in the socket.
 Disconnect and reconnect the probe.
 Cycle instrument power.
 Contact MACIO for service if the problem persists.
 Paired to Printer:
o Check that the printer is turned on.
o Move closer to the printer.
o Try again.
 Paired to PC Computer or Bluetooth® 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.
 Check BT device (printer or PC) status.
 Attempt to connect to BT device again.
 Contact MAICO if the problem persists.
 Printing has been attempted, but no BT device is paired with the
ERO•SCAN® Instrument. Establish Bluetooth® pairing.
 The printer is not responding to queries from the instrument.
Check printer status.
 Awaken printer from sleep mode.
 Charge printer battery if necessary.
 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.
 For a DP test, the desired level (L1 or L2) cannot be obtained
within allowable limits. User should refit the probe and retry the
test.
 Replace the probe tube.
 Contact MAICO for service if the problem persists across several
patients.
 For a DP test, the level of the calibration tone is too high. User
should refit the probe and retry the test.
 Replace the probe tube.
 Contact MAICO for service if the problem persists across several
patients.
 For a DP test, the level of the calibration tone is too low. User
should refit the probe and retry the test.
 Replace the probe tube.
 Contact MAICO for service if the problem persists across several
patients.
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Message
Limit
Error
Printer Paper Out!
Solutions
 Overflow error during the calculation of the DFTs for a DP test.
User should repeat the test.
 Cycle instrument power.
 Contact MAICO for service if the problem persists.
 Saved tests are within 5 tests of the maximum limit. Print or
transfer test result to avoid interruption in testing.
 The maximum saved test limit is reached. The user will need to
clear the memory before any additional tests can be performed.
 The battery charge level is too low for operation. The user must
charge the battery before additional tests can be performed.
 Indicates a problem with the printer. Check the printer status.
 Reset the printer or cycle the printer power.
 Replace the paper roll.
Time/Date Error

Memory almost full
Memory Full!
Power Low!
Printer 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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21 Specifications
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 @ 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
20 hours on-time
Dimensions and Weight:
Dimensions: W X D X H 2.58 X1.23 X 5.78 in.
Instrument Weight: 180 g (6.4 oz.)
User Interface:
Liquid-Crystal 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 Bluetooth 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:
Output:
Input
UE08WCP-050160SPA
5.0 V DC, 1.6 A
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
Temperature:
5° C to 40° C (41° F to 104° F)
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Appendix A: Flowcharts
A.1 Test Operation Flowchart
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A.2 Setup Menu Flowchart
NOTE: DPOAE Menu and TEOAE Menu are not accessible in the ERO•SCAN® Screening version.
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Appendix B: Test Sequence
A complete test sequence consists of an AutoStart, calibration, and test phase. The AutoStart
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 AutoStart phase of the test begins. AutoStart
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,
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: 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 moderatelysevere 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 17) 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: 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.
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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
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
# of
Averaging
Freq.
F2 Freq. [kHz] L1/L2 Time
Screening
4
2.0, 3.0, 4.0, 65/55 4 sec
5.0
DP 2s
4
2.0, 3.0, 4.0, 65/55 2 sec
5.0
Diagnostic DP2.04
2.0, 3.0, 4.0, 65/55 4 sec**
5.0
5.0
DP1.56
1.5, 2.0, 3.0, 65/55 4 sec.**
6.0
4.0, 5.0, 6.0
DP1.66
1.6, 2, 2.5, 65/55 4 sec.**
4.0
3.2, 3.6, 4
DP4.56
4.5, 5, 5.6, 65/55 4 sec.**
8.0
6.3, 7.1, 8
DP2.06
2.0, 4.0, 6.0, 65/55 4 sec.**
12.0
8.0,
10.0,
12.0
(Diagnostic version also includes DP 4s screening protocol)
Name
DP 4s
Pass
SNR
6 dB
# Passing Freq.
for Test Pass
3
6 dB
3
0
dB**
0
dB**
0
dB**
0
dB**
0
dB**
0**
0**
0**
0**
0**
TEOAE Protocols
# of Freq. Freq.
center Averaging
Name
Bands
bands [kHz]
Time (max)
Screening TE 64s 6
1.5, 2, 2.5, 3, 64
3.5, 4.0
TE 32s 6
1.5, 2, 2.5, 3, 32
3.5, 4.0
Diagnostic TE1.56
1.5, 2, 2.5, 3, 64 sec**
4.0
3.5, 4.0
TE0.76
0.7, 1.0, 1.4, 64 sec.**
4.0
2.0, 2.8, 4.0
(Diagnostic version also includes TE64s screening protocol)
Pass
SNR
4 dB
# Passing Freq.
for Test Pass
3
4 dB
3
0
dB**
0
dB**
0**
0**
** Customizable fields:
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 6
57
8105730 Rev B
ERO•SCAN® Operating Instruction
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 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 Safety
2. IEC/EN 60601-1: Medical
Requirements for Safety
Electrical
Equipment,
Part
1
General
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 60601-1-1: Collateral Standard, Safety Requirements for Medical
Electrical Systems
5. IEC/EN 60601-1-2: Medical Electrical Equipment, Part 1 - Electromagnetic
Compatibility - Requirements and Tests
6. Essential Requirements of the current European Union Medical Device
Directive 93/42/EEC
7. RoHS (Restriction of the use of certain Hazardous Substance)
8. WEEE (Waste Electrical & Electronic Equipment) Legislation
58
8105730 Rev B
ERO•SCAN® Operating Instruction
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 internal
CISPR 11
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 commercial,
CISPR 11
industrial, business, hospital, and residential
environments.
Harmonic Emissions
Class A Category
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.
Separation distance according to frequency of transmitter
Rated Maximum
m
Output Power of
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
0.1
1
10
100
0.12
0.12
0.23
0.37
0.37
0.74
1.17
1.17
2.33
3.70
3.70
7.37
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: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
59
8105730 Rev B
ERO•SCAN® Operating Instruction
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
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.
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. If
±8 kV air
±8 kV air
floors are covered with
IEC 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 typical
±1 kV for input/output
±1 kV for input/output
commercial, hospital, or
IEC 61000-4-4
lines
lines
residential environment.
Surge
±1 kV differential mode
±1 kV differential mode
Mains power quality
should be that of a typical
IEC 61000-4-5
±2 kV common mode
±2 kV common mode
commercial, hospital, or
residential environment.
Voltage Dips, Short
<5% UT
<5% UT
Mains power quality
Interruptions and
(>95% dip in UT) for 0.5 (>95% dip in UT) for 0.5 should be that of a typical
Voltage Variations on
cycle
cycle
commercial, hospital, or
Power Supply Lines
40% UT
40% UT
residential environment. If
(60% dip in UT) for 5
(60% dip in UT) for 5
the user of the Ero Scan
IEC 61000-4-11
cycles
cycles
requires continued
70% UT
70% UT
operation during power
(30% dip in UT) for 25
(30% dip in UT) for 25
mains interruptions, it is
cycles
cycles
recommended that the
5% UT
5% UT
Ero Scan be powered
(>95% dip in UT) for 5
(>95% dip in UT) for 5
from an uninterrupted
sec
sec
power supply.
Power Frequency (50/60
3 A/m
3 A/m
Power frequency
Hz)
magnetic fields should be
at levels characteristic of
IEC 61000-4-8
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.
60
8105730 Rev B
ERO•SCAN® Operating Instruction
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
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.
Immunity Test
IEC 60601 Test
Compliance
Electromagnetic 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: 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.
61
8105730 Rev B
Specifications are subject to change without notice
MAICO Diagnostic
7625 Golden Triangle Drive
Eden Prairie, MN 55344
Tel.: 888.941.4201
Fax: 952.278.4481
E-mail: [email protected]
Internet: www.maico-diagnostics.com
8105730 Rev B
3/14 (D-0103992)
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