Maico easyTone Operation Manual
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Maico easyTone Operation Manual

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Operation Manual
easyTone

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  • Page 1 Operation Manual easyTone...

  • Page 3: Table Of Contents

    Introduction ........................3 Intended Use Statement ..................3 Indications for Use Statement ................3 Contraindications of Use ..................3 Features and Benefits of easyTone ................ 3 Description ......................4 For Your Safety......................5 How to Read this Operation Manual ............... 5 Customer Responsibility ..................
  • Page 4 Copyright © 2022 – MAICO Diagnostics. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO. The information in this publication is proprietary to MAICO.

  • Page 5: Introduction

    1.2 Indications for Use Statement The easyTone is a portable or standalone audiometer intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of the hearing loss in the age range of children to adults.

  • Page 6: Description

    Operation Manual easyTone 1.5 Description The easyTone audiometer is designed to be a device for screening for hearing loss. Output 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.

  • Page 7: For Your Safety

    2.1 How to Read this Operation Manual This Operation Manual contains information pertinent to the use of the MAICO device system including safety information as well as maintenance and cleaning recommendations.

  • Page 8: Customer Responsibility

    Section 2.3 Section 3.1 Warranty NOTE: In the unlikely case of a serious incident, inform MAICO as well as the competent authority in the country where the user is established. 2.3 Manufacturer’s Liability Usage of the device in a way deviant from the intended use leads to a limitation or termination of the manufacturer’s liability in case of damage.

  • Page 9: Regulatory Symbols

    Operation Manual easyTone 2.4 Regulatory Symbols Serial number Date of manufacture Manufacturer Caution, consult accompanying documents Warning, consult accompanying documents Information sign (reference for more detailed information) Return to authorized representative, special disposal required Reference number Medical Device UDI information: (01) GTIN (Global Trade Item Number), (11)

  • Page 10: General Precautions

    WARNING liquids. 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. 2.6 Electrical and Electrostatic Safety This icon indicates that patient applied parts of the device conform to IEC 60601-1 Type B requirements.
  • Page 11 Operation Manual easyTone Data transfer to the PC can be done via WiFi or USB connection. WARNING To learn how to safely establish a PC connection with a power supplied PC or laptop via USB connection (medical device/non- medical device) or to a battery-driven laptop see: Section 4.3...

  • Page 12: Electromagnetic Compatibility (Emc)

    To avoid the risk of electric shock, this equipment must only WARNING be connected to the medical power supply originally delivered by MAICO. Using another power supply can also lead to electrical damage on the device. Prevent cable breakage: cables must not be bent or WARNING buckled.

  • Page 13: Cyber Security And Data Protection

    Operation Manual easyTone 2.8 Cyber Security and Data Protection To ensure data protection it is essential to follow common practice in terms of cyber security. This involves: 1. Ensure operating systems are security patched 2. Keep your software up to date.

  • Page 14: Device Control

    Operation Manual easyTone Permanent Deletion of Test Data NOTE: We recommend permanently deleting the test data before selling the easyTone system to protect personal data to protect personal data from misuse. To permanently delete test data, proceed as follows: Press the easyTone app icon until the info selection dialog box opens (Figure 1).

  • Page 15: Warranty, Maintenance And After-Sales Service

    3.1 Warranty 3.1.1 General The MAICO device is guaranteed for at least 1 year. Ask your authorized local distributor for more information. This warranty is extended to the original purchaser of the device by MAICO through...
  • Page 16 MAICO, and shall not include or extend to any claim for or right to recover any other damages, including but not limited to, loss of profit, data, or use of the SOFTWARE, or special, incidental or consequential damages, or other similar claims, even if MAICO has been specifically advised of possibility of such damages.

  • Page 17: End User License Agreement (Tablet)

    In the event that any legal or commercial dispute or controversy arising out of, or relating to this agreement; provided MAICO is in all case violated of the rights, to the SOFTWARE or other intellectual property protection right related to the SOFTWARE;...

  • Page 18: Cleaning And Disinfection Recommendations

    For cleaning the tablet follow the instructions of the manufacturer of the tablet. • Disinfect the plastic housing of the easyTone and its accessories by wiping the surfaces with wet disinfectant wipes. Follow the instructions on the specific disinfection product.

  • Page 19: Recycling And Disposal

    Within the European Union it is illegal to dispose of electric and electronic waste as unsorted municipal waste. According to this, all MAICO products sold after August 13, 2005, are marked with a crossed-out wheeled bin. Within the limits of...

  • Page 20: Unpacking And Hardware Orientation

    4.1 Unpacking the System Check Box and Contents for Damage • It is recommended that you unpack your easyTone and the tablet carefully making sure that all components are removed from the packing materials. • Verify that all components are included as shown on the packing slip included with your shipment.
  • Page 21 Operation Manual easyTone Components The easyTone comes with different components (see Table 1). The availability of configurations with the following components is country specific. Contact your local distributor for more information. Table 1 Components Components easyTone Audiometer Headphones* easyTone App...

  • Page 22: Hardware Orientation

    Operation Manual easyTone 4.2 Hardware Orientation 4.2.1 easyTone Device Figure 4 shows the easyTone headphones, the tablet, the optional patient response switch and the carrying bag. Figure 4 4.2.2 Connections Insert plugs with care into the appropriate connection. Do not wiggle the plug or pull with force while connected.

  • Page 23: Establishing A Pc Connection

    Operation Manual easyTone 4.3 Establishing a PC Connection Data transfer to a PC can be done via USB connection. If the easyTone is used with office equipment that is not a medical device itself (see Table 2, PC Connection 1), make sure to establish the PC connection in one of the following ways (see Table 2, PC Connection 2, 3 or 4).

  • Page 24: Powering

    Connect the USB-C splitter to the tablet and plug in the connectors for the power supply unit and the easyTone audiometer headphones. NOTE: When you are not using the easyTone, you should turn off the tablet and disconnect the easyTone headphones from the tablet; otherwise, it will continue to consume power.

  • Page 25: Operating The Device

    5.1.2 Where to Setup The easyTone should be operated in a quiet room, so that the audiometric examinations are not influenced by outside noises. Ambient sound pressure levels in an audiometric test room shall not exceed the values specified in ISO 8253 series or ANSI S3.1.

  • Page 26: Android Tm Navigation

    Manage Protocols allows the test seen to be adapted to the specific screening guidelines of the location. This is one of the first functions that should be completed when easyTone is received to utilize the full benefit of the device. 5.5.1 Entering the Manage Protocols Screen To enter the Manage Protocols screen, press: to open the menu.
  • Page 27 Operation Manual easyTone 5.5.2 Creating a New Protocol or Changing a Protocol You can create your own protocols according to your screening guidelines and modify them later if needed. Press: to open the New Protocol screen OR to enter the Edit Protocol screen.
  • Page 28 Operation Manual easyTone Set the level for each frequency (Figure 11). Choose the frequency order for each ear Press to proceed. (Figure 12). Touch and drag the window with the frequency to the desired position. Press to proceed. Figure 11...
  • Page 29 Operation Manual easyTone 5.5.4 Sharing a Protocol NOTE: You can use various apps to share the protocols (e.g., e-mail or cloud drives). Apps can be installed according to your needs. Keep in mind general recommendations on Cyber Security and Data Protection.

  • Page 30: Testing

    Operation Manual easyTone 5.6 Testing 5.6.1 Preparing for Testing 5.6.1.1 Preparing the Subject The subject should sit at a distance of at least 1 m from the device. Prior to hearing threshold level measurements, the following instructions should be given.
  • Page 31 Operation Manual easyTone 5.6.3 Selecting a Subject 5.6.3.1 General Settings – Basic Section 5.11.2 According to the settings made, the app starts with • the Screening List screen (see Section 5.6.3.3) • the Single Screening screen (see Section 5.6.3.2). NOTE: From both screens it is possible to start a Quick Test without having created a subject beforehand.
  • Page 32 Operation Manual easyTone 5.6.3.3 Selecting a Subject from the Screening List Figure 20 shows the Screening List. Table 3 provides further explanations. Figure 20 Table 3 Screening List No. Item Information The Screening List shows the data of the subjects and the overall Screening test result if available.
  • Page 33 Operation Manual easyTone 5.6.3.4 Adding a New Subject to Screening List To enter a new subject to the Screening List, press and proceed as follows (Figure 21): 1. Fill in the entry fields. NOTE: You can save the subject as soon as you have filled in at least one of the entry fields.
  • Page 34 Operation Manual easyTone 5.6.5 Testing Figure 25 shows the test screen. For testing proceed as follows: Figure 25 1. Change the selected protocol if needed. 2. Press to select the ear. The ear changes automatically once all frequencies have been tested.
  • Page 35 Operation Manual easyTone 5.6.6 Conditioning the Subject Conditioning or training the subject on what to listen for is done before the hearing screening begins. This allows the subject to know what to respond to at an elevated hearing level. Set the preferred conditioning level with the arrows and then select the blue button between the arrows to present the tone.

  • Page 36: Test Result - Screen Layout

    Selecting a Screener Displays subject. An Edit icon is displayed only for subjects Subject/ entered within the easyTone App. Subjects imported from the Edit easyTone Companion Software cannot be edited. The overall result is displayed as Pass or Refer. Overall...

  • Page 37: Add Notes

    The settings are managed centrally. The settings are shared among all users. The easyTone Companion Software allows for Screening Lists to be loaded onto the tablet. This is for ease in a mass screening and in the documentation process.
  • Page 38 Applications window (Figure 31). drag and drop (Figure 30). Figure 31 Figure 30 To start the easyTone Companion Software, open the Applications window under Go → Applications (Figure 32) and double-click the App icon. The app icon is now displayed in the taskbar.
  • Page 39 Operation Manual easyTone 5.9.3 easyTone Companion Software – Screen Layout Figure 33 Table 5 Name(s) / Description Function (s) CONNECT DEVICE button or connected device (IP address) Connection Connecting the Tablet to the easyTone Section 5.9.4 Companion Software Select to find subject file to import in the directory.
  • Page 40 Connection via WiFi 1. Connect the tablet and the PC to the same WiFi network. 2. Start the easyTone App on the tablet and make sure the tablet does not enter standby mode. 3. Start the easyTone Companion Software on the PC.
  • Page 41 USB Connection NOTE: You must establish the USB connection before each transfer. Make sure to use the USB-C cord delivered by MAICO. Other USB cords might be for charging only. When connecting the tablet to your PC or laptop, proceed as follows: 1.
  • Page 42 8. Select the USB device (Figure 41). The successful connection is indicated by a green check mark. Figure 41 9. Press . The connected tablet is displayed in the easyTone Companion Close Software (Figure 42). Figure 42 8529689 Rev. 2...
  • Page 43 1. Press 2. Select the file in the directory and press Open. 3. Associate import file columns to subject columns in the easyTone Companion Software by selecting from the drop-down menu and press IMPORT (Figure 43). NOTE: Columns that are not associated will not be imported.
  • Page 44 Edit Subject window which is structured like the Add New Subject window. NOTE: You can also delete a subject in the Screening List in the easyTone App. Furthermore, it is possible to start a Quick Test and save the result to the Screening List.
  • Page 45 Operation Manual easyTone 5.9.8 Upload Screening List to Tablet NOTE: Make sure the Screening List in the easyTone App on the tablet is empty before importing or creating a new list from the easyTone Companion Software. Press to upload the Screening List from the easyTone Companion Software on the PC or Mac to the easyTone App on the tablet.
  • Page 46 Operation Manual easyTone 5.9.11 easyTone Companion Software – Settings shows the Settings menu of the easyTone Companion Software (Figure 50). Figure 50 Language (1) Select a language from the drop-down menu. Restart the easyTone Companion Software to let the change take effect.

  • Page 47: Managing Test Results

    Third-party software is displayed by pressing the arrow. Figure 52 NOTE: The easyTone Companion Software logs data about the tablet on which it is installed for support reasons. Further, the easyTone App may log data about its usage patterns and anonymous usage data from test sessions on the manufacturer’s servers administered by the manufacturer.
  • Page 48 Operation Manual easyTone 5.10.2.2 Sharing Test Results from the easyTone App Press to open the Share Menu (Figure 53). Select an app to share the test result (PDF file). Figure 53 5.10.2.3 Printing Test Results Press on the Result screen and the print preview opens.

  • Page 49: Settings

    Operation Manual easyTone 5.10.3 Understanding the PDF Report Figure 55 gives explanation to the PDF report. Facility information and logo Subject data Screening Test date Result (overall and single results) Product information Notes Screener Name Figure 55 5.11 Settings 5.11.1 General To change settings press (Figure 56 and Figure 57): to open the menu.
  • Page 50 Subject data are entered on the start screen. NOTE: When activating the screening mode, the first time, you need to ALLOW the easyTone App to access photos and media on your device (Figure 60). Otherwise, you will not be able to create screening lists or use the easyTone Companion Software.
  • Page 51 Operation Manual easyTone 5.11.3 Settings – Noise Monitor Maximum Permissible Ambient Noise Levels (MPANLs) specifies the limit of how much noise the headphones can be exposed to before noise will infiltrate and might affect the audiometric test. These values are defined in national and international standards.

  • Page 52: Device Information

    It is possible to create a list of screeners (Figure 66). The name of the screener will be displayed on the PDF report/printout and in the export files and can be selected from the start screen. Furthermore, when starting the easyTone App, a toast message welcomes the screener last selected.

  • Page 53: About

    The About screen shows information about the easyTone App (Figure 68). NOTE: The easyTone App logs data about the tablet on which it is installed for support reasons. Further, the easyTone App may log data about its usage patterns and anonymous usage data from test sessions on the manufacturer’s servers administered...

  • Page 54: Updating The Easytone App

    Internet (Figure 69). Press YES PLEASE! to start the update. Figure 69 If you update the easyTone App the first time, you will need to allow the app to install updates. Press Settings to enter the settings menu (Figure 70). Figure 70 Move the slider to the right to allow updates (Figure 71).

  • Page 55: Calibration Reminder

    App (Figure 74). 5.16 Troubleshooting Problem: You cannot create a patient in the Screening List in the easyTone App. Possible reason: When first using the easyTone App, you have not allowed the easyTone App to access photos and media on your device.

  • Page 56: Technical Data

    ▪ electrical safety, EMC and associated standards 6.1 easyTone Hardware and Software The easyTone is an active, diagnostic medical product according to the class IIa of the Medical Device Regulation (EU) 2017/745. General Information About Specifications The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once every 12 months.
  • Page 57 125 Hz to 8000 Hz: Frequencies are selected per protocol created. Weight easyTone audiometer headphones: 389g / 0.86 lbs W x D X H: 19.1 cm x 9.3 cm x 13.4 cm/ Dimensions 7.5“ x 3.6“ x 5.3“ (excluding connections)
  • Page 58 1 x USB C to B for PC Connection Warm up-time Less than 1 minute after power on (incl. boot-up time) Store Function Stored measurements can be viewed in easyTone App. Distortion 0.3 % typical at full intensity Rise/fall Times ~35 ms EASYTONE COMPANION SOFTWARE –...

  • Page 59: Connection And Pin Assignment

    SBU1 VBUS VBUS SSRXn2 SSTXn2 SSRXp2 SSTXp2 6.3 Calibration Values and Maximum Levels Calibration Values and Max Levels: Headphone easyTone Coupler IEC 60318-1, PTB Report 2018, AAU Report 2018 Frequency Tone RETSPL Tone Sound Attenuation [dB] [Hz] dB re 20µPa...

  • Page 60: Electromagnetic Compatibility (Emc)

    The use of accessories, transducers and cables other than delivered from MAICO, 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.
  • Page 61 Operation Manual easyTone Guidance and manufacturer’s declaration - electromagnetic emissions The easyTone is intended for use in the electromagnetic environment specified below. The customer or the user of the easyTone should assure that it is used in such an environment.
  • Page 62 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the easyTone is used exceeds the applicable RF compliance level above, the easyTone should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as re- orienting or relocating the easyTone.

  • Page 63: Electrical Safety, Emc And Associated Standards

    Operation Manual easyTone 6.5 Electrical Safety, EMC and Associated Standards • IEC 60601-1: 2005 + Corr. 1:2006 + Corr. 2:2007 + AM1:2012/ ANSI/AAMI ES60601- 1:2005 + A2:2010/ CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment, Part 1 General Requirements for Basic Safety and Essential Performance •...

  • Page 64: Checklist For Subjective Audiometer Testing

    Operation Manual easyTone 6.6 Checklist for Subjective Audiometer Testing 8529689 Rev. 2 10/05/2022...
  • Page 65 Specifications are subject to change MAICO Diagnostics GmbH Sickingenstr. 70-71 10553 Berlin Germany Tel.: + 49 30 / 70 71 46-50 Fax: + 49 30 / 70 71 46-99 E-mail: sales@maico.biz Internet: www.maico.biz...

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