Interacoustics Sera - Introduction; About this manual; Intended use; Contraindications

D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN Page 1
1 Introduction
1.1 About this manual
This manual is valid for Sera
TM
version 1.23. This product is manufactured by:
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
Instructions for Use/Additional information:
‘Instructions for use’ contains all the information required to operate this system in a safe and ef f ective
manner but the ’Additional information’ guide is also available to the interested reader. The operator can
refer to these manuals on the manuf acture’s official website.
1.2 Intended use
The Sera
TM
with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders
using Distortion Product Otoacoustic Emissions. The target population f or Sera
TM
with DPOAE includes all
ages.
T
he Sera
TM
with TEOAE is intended f or use in the audiologic evaluation and documentation of ear disorders
using Transient Evoked Otoacoustic Emissions. The target population for Sera
TM
with TEOAE includes all
ages.
T
he Sera
TM
with ABRIS is intended f or use in the audiologic evaluation and documentation of ear and nerve
disorders using auditory evoked potentials f rom the inner ear, the auditory nerve, and the brainstem. The
target population for Sera
TM
with ABRIS is newborns.
T
he Sera
TM
System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors,
hearing healthcare prof essionals 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
is intended in a hospital, clinic, healthcare facility or other suitable quiet environment.
1.3 Contraindications
Contraindications to testing include outer ear surgery, recent stapedectomy, a discharging ear, acute
external auditory canal trauma, discomf ort (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.