Introduction; About This Manual; Intended Use; Contraindications - Interacoustics Sera Instructions For Use Manual

1 Introduction

About this manual

This manual is valid for Sera
Instructions for Use/Additional information:
'Instructions for use' contains all the information required to operate this system in a safe and effective
manner but the 'Additional information' guide is also available to the interested reader. The operator can
refer to these manuals on the manufacture's official website.

Intended use

The Sera with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders
TM
using Distortion Product Otoacoustic Emissions. The target population for Sera
ages.
The Sera with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders
TM
using Transient Evoked Otoacoustic Emissions. The target population for Sera
ages.
The Sera with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve
TM
disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The
target population for Sera
The Sera System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors,
TM
hearing healthcare professionals or personnel with a similar level of education. The device should not be
used without the necessary knowledge and training to understand its use and how results should be
interpreted. The Sera
TM

Contraindications

Contraindications to testing include outer ear surgery, recent stapedectomy, a discharging ear, acute
external auditory canal trauma, discomfort (e.g, severe otitis externa) or occlusion of the external auditory
canal or wounds. Testing should not be performed on patients with such symptoms without a medical
doctor's approval.
For US only: Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a
licensed medical practitioner.
D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
version 1.17. This product is manufactured by:
TM
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: +45 6371 3555
Fax: +45 6371 3522
E-mail: info@interacoustics.com
Web: www.interacoustics.com
with ABRIS is newborns.
TM
is intended in a hospital, clinic, healthcare facility or other suitable quiet environment.
with DPOAE includes all
TM
with TEOAE includes all
TM
Page 1