Operation Manual easyTone
8529689 Rev. 2
3
10/05/2022
1 Introduction
This section offers you important information about:
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the intended use of the device
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indications and contraindications of use
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features and benefits
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a description of the device
1.1 Intended Use Statement
The easyTone is a screening audiometer designed to perform a hearing screening.
The instrument is intended for all patient populations over 3 years of age and able to
respond to a test signal in a rational way.
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. It is used as part of a total test
battery to determine 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, clinic, healthcare facility or other
suitable quiet environment as defined in ISO 8253-1 or ANSI S3.1 or equivalent.
1.3 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.4 Features and Benefits of easyTone
1.4.1 General information about the easyTone
The easyTone gives you the benefit of:
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Portable headphone audiometer with tablet
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Air Conduction screening audiometry
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Site specific screening protocol creation
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Pass or Refer result with report
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Guided workflow
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Start screen adaptability
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Import / export screening lists
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Quick reporting (e-mail, printer, drive)
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Noise monitoring
1.4.2 easyTone Companion Software
The easyTone Companion Software allows you to:
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Import screening list to easyTone app
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Download subject results for easy result management
Summary of Contents for easyTone
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