Introduction; General; Intended Use Statement - Maico easyScreen Operation Manual

1 Introduction

This section offers you important information about:
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the intended use inclusive indications of use of the device
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contraindications of use
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essential performance
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features and benefits
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a description of the device

1.1 General

Thank you for purchasing a quality product from the MAICO product family.
The easyScreen is designed and manufactured to meet all relevant quality and safety
requirements. When designing the easyScreen MAICO placed particular importance
on making it a user-friendly device. The intent was to make its operation easy-to-learn,
thus making the device simple and easy to operate.
This user manual is meant to make it as easy as possible for the operator to become
familiar with the operation and functions of the easyScreen. If you have questions or
suggestions for further improvements, please, do not hesitate to contact MAICO.

1.2 Intended Use Statement

Indications for Use
The device TEOAE and DPOAE modules are intended for use in the audiologic
evaluation and documentation of ear disorders using Transient Otoacoustic Emissions
technology or Distortion Product Otoacoustic Emissions.
The device ABR module is intended for use in the audiologic evaluation and
documentation of ear and nerve disorders using auditory evoked potentials from the inner
ear, the auditory nerve and the brainstem. It is intended to be used by audiologists, ENTs,
hearing healthcare professionals, or other trained technicians in a hospital, clinic,
healthcare facility or other suitable quiet environment. Hearing screenings are most
successfully and efficiently performed in acoustically quiet surroundings. While this is not
always achievable in a hospital environment, the screener should be aware of acoustic
noise and control it to the extent that this is feasible.
Target population
The target population for the TEOAE and DPOAE modules includes all ages. The
population for the ABR module is newborns and infants up to 6 months of age. The
TEOAE probe fit procedure is optimized for infant ears. Some ears with larger ear canal
volume may not achieve a good probe fit.
It is recommended that screening should be performed when the newborn is medically
stable and is at least 32 weeks postmenstrual age in the case of preterm infants.
8508935 Rev. 4
Operation Manual easyScreen
6 04/04/2019