Maico ERO SCAN User manual

MAICO Diagnostic GmbH, Salzufer 13/14, 10587 Berlin, Germany, Tel. [phone], Fax [phone]
Operating Instruction
ERO•SCAN®
Screening and Diagnostic Version

Operating Instruction
ERO•SCAN®
Screening and Diagnostic Version
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Table of Contents
1Standards Compliance............................................................................. 1
2Warranty .................................................................................................. 2
2.1 Intended Use .......................................................................................................................................2
3Warnings, Cautions, and Errors .............................................................. 3
3.1 Status/Error Messages.........................................................................................................................5
4Customer Responsibility.......................................................................... 6
5Safety 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
6Recycling/Disposal ................................................................................... 9
7Regulatory Symbols............................................................................... 10
8Introduction ........................................................................................... 12
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
9Setup ...................................................................................................... 14
9.1 Unpacking the System ...................................................................................................................... 14
9.2 Battery Charging ............................................................................................................................... 14
9.3 Installing the Micro-Probe................................................................................................................ 16
9.4 Attaching Eartips............................................................................................................................... 17
9.5 Removing Eartips.............................................................................................................................. 17
10 Operating Instructions .......................................................................... 18
10.1 Preparing the Patient for Testing ..................................................................................................... 18
10.2 Turning On the Instrument............................................................................................................... 18
10.3 Control Panel .................................................................................................................................... 18

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10.4 Main Menu ....................................................................................................................................... 19
10.5 Selecting the Test Protocol............................................................................................................... 19
10.6 Probe Check (Beginning a Test) ........................................................................................................ 20
10.7 Calibration and Test.......................................................................................................................... 21
10.8 Viewing Results................................................................................................................................. 22
10.9 Test Technique.................................................................................................................................. 22
10.10 Noise Sources ................................................................................................................................... 23
10.11 Turning Off the Instrument .............................................................................................................. 23
11 Managing Results .................................................................................. 24
11.1 Saving Results ................................................................................................................................... 24
11.2 Deleting Results ................................................................................................................................ 25
11.3 Printing to a Thermal Printer............................................................................................................ 25
11.4 Connecting to the PC Database Software......................................................................................... 26
12 MPT-II Mobile thermal mini printer ...................................................... 27
12.1 Operation.......................................................................................................................................... 28
13 Interpreting Results ............................................................................... 32
13.1 Understanding the Display ............................................................................................................... 32
13.2 SNR Graph View................................................................................................................................ 33
13.3 Value Graph View ............................................................................................................................. 33
14 Interpreting Printed Results .................................................................. 34
14.1 Understanding the DPOAE Printout ................................................................................................. 34
14.2 Understanding the TEOAE Printout.................................................................................................. 35
15 Rounding Results................................................................................... 36
16 Clock and Date/Time Settings............................................................... 37
16.1 Accessing the Clock Menu ................................................................................................................ 37
16.2 Changing the Date/Time................................................................................................................... 37
17 Instrument Settings ............................................................................... 38
17.1 Bluetooth®Device Pairing................................................................................................................. 38
17.2 Clearing Test Results......................................................................................................................... 39
17.3 Auto Shutdown Time ........................................................................................................................ 39
17.4 Save Mode/Storing Test Results....................................................................................................... 40
17.5 Minimum Amplitude......................................................................................................................... 41

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17.6 Clock Mode ....................................................................................................................................... 41
17.7 Graph Style ....................................................................................................................................... 41
17.8 Language........................................................................................................................................... 42
17.9 Reset to Default................................................................................................................................ 42
18 Advanced Options for DPOAE Testing ................................................. 43
18.1 Instructions for Customizing a Test Protocol.................................................................................... 43
18.2 Selecting the Level of Primary Tones................................................................................................ 44
18.3 Setting the Averaging Time .............................................................................................................. 44
18.4 Setting the PASS SNR Level............................................................................................................... 44
18.5 Setting the Number of Frequencies for PASS................................................................................... 45
18.6 Reset Protocol................................................................................................................................... 45
18.7 Save Protocol .................................................................................................................................. 45
19 Advanced Options for TEOAE Testing.................................................. 45
19.1 Instructions for Customizing a Test Protocol.................................................................................... 46
19.2 Selecting the Averaging Time ........................................................................................................... 47
19.3 Setting the PASS SNR Level............................................................................................................... 47
19.4 Setting the Number of Frequencies for PASS................................................................................... 48
19.5 Reset Protocol................................................................................................................................... 48
19.6 Save Protocol .................................................................................................................................... 48
20 Cleaning and Maintenance ................................................................... 49
20.1 Cleaning and Disinfection ................................................................................................................. 49
20.2 Maintenance..................................................................................................................................... 49
20.3 Probe Tube Replacement ................................................................................................................. 50
21 Troubleshooting .................................................................................... 51
22 Specifications ......................................................................................... 54
Appendix A: Flowcharts.............................................................................. 56
A.1 Test Operation Flowchart ....................................................................................................................... 56
A.2 Setup Menu Flowchart ........................................................................................................................... 57
Appendix B: Test Sequence ........................................................................ 58
Appendix C: Pass/Refer Criteria.................................................................. 60
Appendix D: Configurations and Test Protocols........................................ 63
Appendix E: EMC Compatibility ................................................................. 64

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Electromagnetic Compatibility.............................................................................................................. 64
Electrical Safety, EMC and Associated Standards............................................................................. 64
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions.................................... 65
Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the ERO•SCAN®............................................................................................................... 65
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.................................... 66
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.................................... 67

Operating Instruction
ERO•SCAN®
Screening and Diagnostic Version
MAICO Diagnostic
Salzufer 13/14
10587 Berlin
E-mail: [email protected]
Internet: www.maico-diagnostic. biz
EC REP
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 Diagnostics is an ISO 13485 certified corporation.

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1Standards Compliance
Standard
Issue
Date
Title
ANSI/ASA 3.6
2010
Specification for Audiometers
IEC 60601-1
2007
Medical Electrical Equipment –General Requirements for
Basic Safety and Essential Performance, Ed. 3
IEC 60645-1
2004
Electroacoustics –Audiological equipment –Part 1: Pure-
tone audiometers
IEC 60645-3
2007
Electroacoustics –Audiometric equipment –Part 3: Test
signals of short duration
IEC 60645-6
2010
Electroacoustics –Audiometric Equipment –Part 6:
Instruments for the measurement of otoacoustic emissions
ISO 14971
2007
Application of Risk Management to Medical Devices
ISO 10993
2009
Biological Evaluation of Medical Devices
EN 60601-1-2
2007
Medical electrical equipment –Part 1-2: General
requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility –
Requirements and Tests
FCC Part 15
FCC 47CFR, Part 15.247 & 15.249 (Bluetooth®)
UL 60601-1
2005
Clause 8.9.1.8; Pollution Degree Classification: 2

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2Warranty
MAICO Diagnostics warrants that this product is free from defects in material and
workmanship and, when properly used, will perform in accordance with applicable
specifications. If this instrument does not meet these criteria within one year of original
shipment, it will be repaired, or at our option, replaced at no charge when returned to our
service facility.
NOTE: Changes in the product not approved by MAICO Diagnostics shall void this warranty.
MAICO Diagnostics shall not be liable for any indirect, special or consequential damages,
even if notice has been given of the possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
For assistance with this ERO•SCAN®Otoacoustic Emission Test System contact your Special
Equipment Distributor or contact MAICO Diagnostics by phone at 888.941.4201 or by fax
at 952.903.4100.
2.1 Intended Use
The ERO•SCAN®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.

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3Warnings, Cautions, and Errors
In this manual the following two labels identify potentially dangerous or destructive
conditions and procedures.
The WARNING label identifies conditions or practices that may
present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could
result in damage to the equipment
NOTE: Notes help you identify areas of possible confusion and avoid potential problems
during system operation.
The ERO•SCAN®Otoacoustic Emission Test System should be
charged using only the provided power supply. Injury to personnel
or damage to equipment can result when a three-prong to two-
prong adaptor is connected between the ERO•SCAN®power supply
and an AC outlet.
No modifications of the equipment are allowed by anyone other
than a qualified MAICO representative. Modification of the
equipment could be hazardous.
The ERO•SCAN®product has been verified by an independent
laboratory to conform to international standards for EMC
(electromagnetic emissions and immunity). The user is advised to
avoid installation and use of this instrument in proximity with other
devices or equipment that may emit or be susceptible to
electromagnetic interference, including mobile phones. If the
instrument is used adjacent to other devices or equipment, the user
is instructed to verify that no disturbance is found in the operation
of this or other equipment in proximity.
This icon indicates that patient applied parts of the instrument
conform to IEC 60601-1:2005, Type B requirements.
WARNING
CAUTION
WARNING

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Instruments which bear the Underwriters Laboratories, Inc. label
should be interconnected with accessories that have the proper
electrical compatibility and are listed as meeting the requirements of
the UL Medical and Dental Equipment Standard. Connection of
accessories not meeting these requirements may result in electrical
leakage currents in excess of those allowed by the standard and
present a potential electrical shock hazard to the person being
tested.
Any program aimed at obtaining reliable measurements of
otoacoustic emissions should be staffed and supervised by
appropriately-trained individuals.

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

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4Customer Responsibility
This product and its components will perform reliably only when
operated and maintained in accordance with the instructions
contained in this manual, accompanying labels, and/or inserts. A
defective product should not be used. Make sure all connections to
external accessories are snug and secured properly. Parts which may
be broken or missing or are visibly worn, distorted, or contaminated
should be replaced immediately with clean, genuine replacement
parts manufactured by or available from MAICO.
This product should not be used in the presence of fluid that can
come into contact with any of the electronic components or wiring.
Should the user suspect fluids have contacted the system
components or accessories, the unit should not be used until
deemed safe by a MAICO certified service technician.
Do NOT use in the presence of flammable gaseous mixtures. Users
should consider the possibility of explosions or fire when using this
device in close proximity to flammable anesthetic gases.
Do NOT use the ERO•SCAN®in a highly oxygen-enriched environ-
ment, such as a hyperbaric chamber, oxygen tent, etc.
Equipment is not user repairable. Repairs and battery replacement
must be performed by a qualified service representative only.
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.
WARNING
CAUTION

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5Safety 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
If the system is not functioning properly, do not operate it until all
necessary repairs are made and the unit is tested and calibrated for
proper functioning in accordance with MAICO published
specifications.
Use only the disposable eartips designed for use with this
instrument.
Never insert the probe tube into the ear canal without affixing an
eartip.
The eartips are disposable and for single patient use only. Do not
clean or reuse eartips.
Probe tubes are disposable and should be replaced when clogged. If
a probe tube is reused after removal from the probe head, it will not
sit as tight as before.
Do not attempt to clean probe tubes. This may cause damage to
the probe.
Do not drop or otherwise cause undue impact to this device. If the
instrument is dropped or otherwise damaged, return it to the
manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
CAUTION

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5.2 Warning - Electric Shock Hazards
Do not open the case of the ERO•SCAN®Instrument. Refer servicing to
qualified personnel.
Do not touch the contacts on the bottom of the instrument and the
patient at the same time.
Do not connect the instrument to the patient and the PC at the same
time.
5.3 Warning - In Case of Emergency
In case of emergency, disconnect the instrument from the supply
mains by removing the micro-USB cable from the connector as shown
in Figure 2 on page 16.
5.4 Warning - Explosion
This system is not explosion proof. Do not use in the presence of
flammable anesthetics or other gases.
5.5 Warning - Battery Safety
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.
WARNING
WARNING
WARNING

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6Recycling/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 in Europe and other localities.
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
Batteries may explode or cause burns, if disassembled, crushed or
exposed to fire or high temperatures.
WARNING

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7Regulatory Symbols
No.
Symbol
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
B Patient Applied Part According to
IEC60601-1
980 & 60601-1
Consult Operating Instructions
60601-1
Keep Dry
60601-1
Transport and Storage Temperature
range
Logo
EC REP
980 & 60601-1
EU Authorized Representative
980 & 60601-1
Conforms to European Medical
Device Directive 93/42/EEC
REF

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8Introduction
The purpose of the ERO•SCAN®test system is to provide a rapid measurement and
documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked
Otoacoustic Emissions (TEOAEs) at several frequencies.
The ERO•SCAN® is available as a Screening or Diagnostic version. Please see chapter 18 and
19 for further information.
8.1 How Does the ERO•SCAN®Device Work?
The system consists of the instrument,
Micro-Probe, 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 an organic light-emitting
diode (OLED) Display screen and three
light-emitting diodes (LEDs) to provide a
visual Display of test status to the
operator. Four membrane-type push
buttons located on the keypad of the
device allow the user to control testing
and printing, and to reset test protocols.
The Micro-Probe houses speaker and
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.
User Interface
Buttons
Probe Connector
Micro-USB
Connector
Figure 1
Charge Status
Indicator
Display
Test Status
Indicators

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8.2 How are the Results Stored and Reported?
When the ERO•SCAN®is set in its default settings, the instrument will store the results from
one patient (left and right ear) in its non-volatile memory for subsequent printing. However,
the ERO•SCAN®instrument is capable of storing up to 250 test results. The results are
displayed via the OLED on the front of the device and are stored in the device’s internal
memory. After testing is completed, results can be printed using the printer and/or exported
to a computer. Test results are stored in the non-volatile memory so the operator can delay
printing until a later time if desired.
8.3 Sensitivity and Specificity
Sensitivity and specificity of this type of device are based on the test characteristics defined
by the user, and may vary depending on environmental and operating conditions. The
presence of otoacoustic emissions suggests normal outer hair cell function, which in turn
correlates to normal hearing. However, a passing result using this instrument is not an
indication that the full auditory system is normal. Thus, a PASS result should not be allowed
to override other indications that hearing is not normal. A full audiologic evaluation should
be administered if concerns about hearing sensitivity persist. A REFER test result should not
be assumed to be an indicator of a lack of auditory function, however, it should be followed
with full audiologic diagnostic testing.