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Maico easyTone, Operation Manual

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Operation Manual easyTone  

 

 

 

8529689 Rev. 2 

4 

10/05/2022 

 

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. The screening for hearing loss using this kind of audiometer depends on 
the interact

ion with the patient. As with any type of hearing screening, a “pass” result 

should not overrule any additional concerns regarding hearing ability. A full audiologic 
evaluation should be administered if concerns about hearing sensitivity persist. 

Summary of Contents for easyTone

Page 1: ...Operation Manual easyTone...

Page 2: ......

Page 3: ...Replacement Parts 16 3 6 Recycling and Disposal 17 4 Unpacking and Hardware Orientation 18 4 1 Unpacking the System 18 4 2 Hardware Orientation 20 4 3 Establishing a PC Connection 21 4 4 Powering 22...

Page 4: ...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 publicat...

Page 5: ...termine hearing acuity by audiologists ENTs hearing healthcare professionals or other trained technicians under the supervision of a professional such as an audiologist doctor or nurse in a hospital c...

Page 6: ...racteristics defined by the user and may vary depending on environmental and operating conditions The screening for hearing loss using this kind of audiometer depends on the interaction with the patie...

Page 7: ...ns READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this manual All images and screenshots are only examples and may differ in appearance from the actu...

Page 8: ...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 con...

Page 9: ...special disposal required Reference number Medical Device UDI information 01 GTIN Global Trade Item Number 11 Date 21 Serial number Patient applied part type B according to IEC 60601 1 Refer to opera...

Page 10: ...faulty measurements and may cause the examinee to be exposed to loud sounds Ensure that the device does not come into contact with liquids Should the user suspect fluids have contacted the system comp...

Page 11: ...via a separation transformer to reduce the leakage currents Any person who connects external equipment to signal input signal output or other connectors has formed a Medical Electrical System and is t...

Page 12: ...s the relevant EMC requirements Avoid unnecessary exposure to electromagnetic fields e g from mobile phones etc Use of this device adjacent to or stacked with other equipment should be avoided because...

Page 13: ...e up to date 3 Install only apps and software from trusted sources 4 Install an antivirus protection and anti malware software and a firewall from a trusted vendor and keep them up to date 5 Utilize t...

Page 14: ...yTone app icon until the info selection dialog box opens Figure 1 Open the App info and press Storage cache Figure 2 Figure 2 Press CLEAR STORAGE and CLEAR CACHE to permanently delete all test data Fi...

Page 15: ...the device case will void the warranty In the event of repair during the guarantee period please enclose evidence of purchase with the device 3 1 2 Ownership Warranty and Disclaimer Software Ownership...

Page 16: ...cement of defective media or documentation supplied by 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...

Page 17: ...intellectual property protection right related to the SOFTWARE shall be presented under the Jurisdiction of Federal Republic of Germany in the court of Berlin The SOFTWARE is protected under both Cop...

Page 18: ...ries by wiping the surfaces with wet disinfectant wipes Follow the instructions on the specific disinfection product o Wipe before and after each patient o After contamination o After infectious disea...

Page 19: ...with a crossed out wheeled bin Within the limits of Article 9 of DIRECTIVE 2002 96 EC on waste electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additional distrib...

Page 20: ...ributor immediately to report the shortage If any component appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appea...

Page 21: ...he following components is country specific Contact your local distributor for more information Table 1 Components Components easyTone Audiometer Headphones easyTone App Patient Response Switch Tablet...

Page 22: ...he 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 Disconnect plugs cautiously The audiometer h...

Page 23: ...Make sure you use only office equipment with the device that is a medical device itself or meets the requirements of IEC 60950 If a non medical device is used within the patient environment 1 5 m from...

Page 24: ...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 disconn...

Page 25: ...m shall not exceed the values specified in ISO 8253 series or ANSI S3 1 Electronic devices which emit strong electromagnetic fields e g microwaves or radiotherapy devices can influence the function of...

Page 26: ...on bar is an AndroidTM setting option It is recommended to leave the setting as all manual and training materials utilize this view 5 5 Managing Protocols Manage Protocols allows the test seen to be a...

Page 27: ...r if needed Press to open the New Protocol screen OR and Edit to enter the Edit Protocol screen Protocol wizard will start and leads you through protocol options e g Figure 8 single steps Figure 9 to...

Page 28: ...s to proceed Figure 11 Figure 12 To allow a Pass result for each frequency Figure 13 after 2 responses activate setting after 1 response deactivate setting Press to proceed Select the signal type Figu...

Page 29: ...nstalled on the tablet Press and Share to share a single protocol to share all protocols Select the app for sharing Figure 15 and complete the sharing process in the app or save the file in the direct...

Page 30: ...n your area 5 6 1 2 Placement of Headphones Figure 17 Eliminate any obstructions which will interfere with the placement of the ear cushions on the ear i e hair eyeglasses Ensure that the headphones F...

Page 31: ...ning 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 Section 5 6 3 5 Quick Start 5 6 3 2 Entering a Subject in Single...

Page 32: ...List by Id Last Name First Name or Other 3 Filter the list by No test Pass Refer or Could not test 4 Section 5 6 2 Selecting a Screener 5 Sort the list by ID Last Name First Name Date of Birth or Othe...

Page 33: ...ng List mode and in Single Screening mode Press to start the test and proceed as normal Single Screening On the Result screen you can add the Subject information Press above Screening Result to go to...

Page 34: ...ing conditions if needed green ideal yellow okay red too loud testing conditions need to be improved 4 Condition the subject Section 5 6 6 Conditioning the Subject 5 Present a tone 6 Press if the subj...

Page 35: ...itioning level with the arrows and then select the blue button between the arrows to present the tone There are a variety of conditioning levels available to select and even can be used to gradually r...

Page 36: ...ection 5 10 2 2 Sharing Test Results 4 Opens AndroidTM printing application Section 5 10 2 3 Printing Test Results 5 Section 5 6 2 Selecting a Screener 6 Subject Edit Displays subject An Edit icon is...

Page 37: ...ared 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 5 9 2 Installing the...

Page 38: ...he Applications folder by drag and drop Figure 30 Follow the installation progress in the Applications window Figure 31 Figure 30 Figure 31 To start the easyTone Companion Software open the Applicatio...

Page 39: ...Select to find subject file to import in the directory Section 5 9 5 Import Subject to easyTone Companion Software 3 To manually add subject Section 5 9 6 Add New Subject 4 Screening List Shows import...

Page 40: ...t does not enter standby mode 3 Start the easyTone Companion Software on the PC 4 Press and select WiFi Figure 34 Figure 34 5 Enter the IP address and press SEARCH or search the tablet by pressing SCA...

Page 41: ...o your PC or laptop proceed as follows 1 Connect the tablet to the PC with the USB cord 2 Allow access on the tablet 3 Swipe down from the top to display the Silent Notifications and locate the Androi...

Page 42: ...2 7 Press and select USB Figure 40 Figure 40 8 Select the USB device Figure 41 The successful connection is indicated by a green check mark Figure 41 9 Press Close The connected tablet is displayed in...

Page 43: ...s file can be exported from an already utilized database or manually created Proceed as follows 1 Press 2 Select the file in the directory and press Open 3 Associate import file columns to subject col...

Page 44: ...y pressing the icons in the Actions column Figure 45 Figure 45 Press to delete a subject after further confirmation Press to edit the subject in the Edit Subject window which is structured like the Ad...

Page 45: ...Press to download the Screening List from the easyTone App to the easyTone Companion Software Figure 47 Figure 47 Press Yes to overwrite the existing Screening List Press No to keep the existing Scree...

Page 46: ...ck 3 Enable this feature to automatically check for updates New updates are displayed after restarting the app Press 4 to perform the update Update 4 Press the button to manually search for updates Pr...

Page 47: ...are used for future development All data logged is anonymous and is therefore not covered by EU GDPR consent No individual can be identified and therefore the manufacturer is not able to or obliged to...

Page 48: ...gure 53 5 10 2 3 Printing Test Results Press on the Result screen and the print preview opens Press 1 to open further printer settings if needed Save as PDF Press 2 select the storage location and pre...

Page 49: ...11Settings 5 11 1 General Figure 56 To change settings press Figure 56 and Figure 57 to open the menu Settings to open the main Settings menu Figure 57 Basic Noise Monitor Report or Screeners to enter...

Page 50: ...one Companion Software Single Screening To screen only a single subject Subject data are entered on the start screen NOTE When activating the screening mode the first time you need to ALLOW the easyTo...

Page 51: ...rnational standards Select the standard you want to apply Figure 62 Figure 62 5 11 4 Settings Report Figure 63 Page size Select the wanted page size for the report Figure 63 NOTE The page size can sti...

Page 52: ...t 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 Section 5 6 2 Selecting a Screener Pr...

Page 53: ...may log data about its usage patterns and anonymous usage data from test sessions on the manufacturer s servers administered by the manufacturer They are used for future development All data logged i...

Page 54: ...ress 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...

Page 55: ...Basic Problem You cannot upload a Screening List from the easyTone Companion Software to the easyTone App Possible reason When first using the easyTone App you have not allowed the easyTone App to ac...

Page 56: ...d specifications of the device can only be guaranteed if it is subject to technical maintenance at least once every 12 months MAICO Diagnostics puts diagrams and service manuals at the disposal of aut...

Page 57: ...s are located in the easyTone Service Manual Air Conduction easyTone RadioEar Standard Values Transducers Headband tension easyTone Headband Static Force 10 0 N 0 7 N Patient Response switch One push...

Page 58: ...ical at full intensity Rise fall Times 35 ms EASYTONE COMPANION SOFTWARE SYSTEM REQUIREMENTS PC Requirements 2 GHz Intel Core 2 Duo CPU 2 GB RAM 1 GB available disk space USB drive Display Requirement...

Page 59: ...B4 VBUS A10 SSRXn2 B3 SSTXn2 A11 SSRXp2 B2 SSTXp2 A12 GND B1 GND 6 3 Calibration Values and Maximum Levels Calibration Values and Max Levels Headphone easyTone Coupler IEC 60318 1 PTB Report 2018 AAU...

Page 60: ...e as specified in Table 6 Table 6 EMC Requirements Accessories ITEM MANUFACTURER MODEL CABLE LENGTH M SCREENED YES NO Headphone Audiometer RadioEar DD65 v2A easyTone 1 9 Yes Patient Response Switch DG...

Page 61: ...tput 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 s...

Page 62: ...eld strengths 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...

Page 63: ...uipment Part 1 2 General Requirements for Basic Safety and Essential Performance Collateral Standard Electromagnetic Compatibility Requirements and tests ISO 14971 2019 Application of risk management...

Page 64: ...Operation Manual easyTone 8529689 Rev 2 62 10 05 2022 6 6 Checklist for Subjective Audiometer Testing...

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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