ERO.SCAN Screening and Diagnostic Plus Version Operating Instructions July 2014

Operating Instruction ERO•SCAN® Screening and Diagnostic Plus Version

Table of Contents 1

Standards Compliance ... 1

2

Warranty ... 2 2.1

3

Intended Use ...2

Warnings, Cautions, and Errors ... 3 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 ... 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

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Control Panel ... 18

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 ... 31 13.1

Understanding the Display ... 31

13.2

SNR Graph View ... 32

13.3

Value Graph View ... 32

14 Interpreting Printed Results ... 33 14.1

Understanding the DPOAE Printout ... 33

14.2

Understanding the TEOAE Printout ... 34

15 Rounding Results ... 35 16 Clock and Date/Time Settings ... 36 16.1

Accessing the Clock Menu ... 36

16.2

Changing the Date/Time ... 36

17 Instrument Settings ... 37 17.1

Bluetooth® Device Pairing ... 37

17.2

Clearing Test Results ... 38

17.3

Auto Shutdown Time ... 38

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Save Mode/Storing Test Results ... 39

17.5

Minimum Amplitude... 40

17.6

Clock Mode ... 40

17.7

Graph Style ... 40

17.8

Language ... 41

17.9

Reset to Default ... 41

18 Advanced Options for DPOAE Testing ... 42 18.1

Instructions for Customizing a Test Protocol... 42

18.2

Selecting the Level of Primary Tones... 43

18.3

Setting the Averaging Time ... 43

18.4

Setting the PASS SNR Level ... 43

18.5

Setting the Number of Frequencies for PASS ... 44

18.6

Reset Protocol... 44

18.7

Save Protocol ... 44

19 Advanced Options for TEOAE Testing ... 45 19.1

Instructions for Customizing a Test Protocol... 45

19.2

Selecting the Averaging Time ... 46

19.3

Setting the PASS SNR Level ... 46

19.4

Setting the Number of Frequencies for PASS ... 47

19.5

Reset Protocol... 47

19.6

Save Protocol ... 47

20 Cleaning and Maintenance ... 48 20.1

Cleaning and Disinfection ... 48

20.2

Maintenance ... 49

20.3

Probe Tube Replacement ... 49

21 Troubleshooting ... 50 22 Specifications ... 53 Appendix A: Flowcharts ... 55 A.1 Test Operation Flowchart ... 55 A.2 Setup Menu Flowchart ... 56

Appendix B: Test Sequence ... 57 operating_instructions_8106556-4_EROSCAN_Plus_e_14c

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Operating Instruction ERO•SCAN® Screening and Diagnostic Plus Version Appendix C: Pass/Refer Criteria ... 59 Appendix D: Configurations and Test Protocols... 62 Appendix E: EMC Compatibility ... 63 Electromagnetic Compatibility ... 63 Electrical Safety, EMC and Associated Standards ... 63 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions... 64 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the ERO•SCAN®... 64 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ... 65 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ... 66

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Operating Instruction ERO•SCAN® Screening and Diagnostic Plus 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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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 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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3 Warnings, Cautions, and Errors In this manual the following two labels identify potentially dangerous or destructive conditions and procedures. WARNING

The WARNING label identifies conditions or practices that may present danger to the patient and/or user.

CAUTION

The CAUTION label identifies conditions or practices that could result in damage to the equipment

NOTE: Notes help you identify areas of possible confusion and avoid potential problems during system operation.

WARNING

The ERO•SCAN® Otoacoustic Emission Test System should be charged using only the provided power supply. Injury to personnel or damage to equipment can result when a three-prong to 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. This icon indicates that patient applied parts of the instrument conform to IEC 60601-1:2005, Type B requirements.

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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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Status/Error Messages

Display Messages: No probe is detected at the start of a test. Attach Probe The paired Bluetooth® device cannot be detected. The device may be turned BT Device Not off or too far away. Found There is an error condition with the Bluetooth® device. Check the status. BT Error #xxx The ERO•SCAN® instrument is not paired with any Bluetooth® device. BT Not Configured The printer is not responding to queries from the instrument. Device not Responding Due For Service Indicates calibration of instrument is recommended. Message will appear 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

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. Probe tubes are disposable and should be replaced when clogged. If a probe tube is reused after removal from the probe head, it will not sit as tight as before. Do not attempt to clean probe tubes. This may cause damage to the probe. Do not drop or otherwise cause undue impact to this device. If the instrument is dropped or otherwise damaged, return it to the manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected.

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Warning - Electric Shock Hazards WARNING

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

5.3

Warning - In Case of Emergency In case of emergency, disconnect the instrument from the supply mains by removing the micro-USB cable from the connector as shown in Figure 2 on page 16.

5.4

Warning - Explosion WARNING

5.5

Warning - Battery Safety WARNING

5.6

This system is not explosion proof. Do not use in the presence of flammable anesthetics or other gases.

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.

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 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

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 B Patient Applied Part According to IEC60601-1

60601-1

980 & 60601-1

Consult Operating Instructions

60601-1

Keep Dry

60601-1

Transport and Storage Temperature range Logo

EC REP

980 & 60601-1

980 & 60601-1

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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 a Screening or Diagnostic version. Please see chapter 18 and 19 for further information.

8.1

How Does the ERO•SCAN® Device Work?

Probe Connector Test Status Indicators

Display

User Interface Buttons Charge Status Indicator

Micro-USB Connector

Figure 1

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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.

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How are the Results Stored and Reported?

When the ERO•SCAN® is set in its default settings, the instrument will store the results from one patient (left and right ear) in its non-volatile memory for subsequent printing. However, the ERO•SCAN® instrument is capable of storing up to 250 test results. The results are displayed via the OLED on the front of the device and are stored in the device’s internal memory. After testing is completed, results can be printed using the printer and/or exported to a computer. Test results are stored in the non-volatile memory so the operator can delay printing until a later time if desired.

8.3

Sensitivity and Specificity

Sensitivity and specificity of this type of device are based on the test characteristics defined by the user, and may vary depending on environmental and operating conditions. The presence of otoacoustic emissions suggests normal outer hair cell function, which in turn correlates to normal hearing. However, a passing result using this instrument is not an indication that the full auditory system is normal. Thus, a PASS result should not be allowed to override other indications that hearing is not normal. A full audiologic evaluation should be administered if concerns about hearing sensitivity persist. A REFER test result should not be assumed to be an indicator of a lack of auditory function, however, it should be followed with full audiologic diagnostic testing.

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9 Setup 9.1

Unpacking the System

The following is a list of parts shipped with each ERO•SCAN® system:          

ERO•SCAN® Instrument Micro-Probe Box of Single Use Eartips Package of Probe Tubes Eartip Remover 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 NOTE: We highly recommend to use SanibelTM eartips in order to guarantee optimal test results. If any of these parts are missing or you want to order optional accessories or Sanibel disposables, contact your special equipment distributor or MAICO Diagnostic at (+49) 30 70 71 46-50. We recommend that you save the shipping box and packing materials in case you need to store or ship the system.

9.2

Battery Charging

The ERO•SCAN® instrument is powered by an integrated rechargeable lithium-ion battery (1800 mAh) providing 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 1, page 19). 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. operating_instructions_8106556-4_EROSCAN_Plus_e_14c

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