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1 Introduction
About this manual
T
his manual is valid for VisualEyes™ 505 software version 3.0. This product is manufactured by:
Definitions:
Wherever 'operator' is mentioned in this document, this refers to a clinician, technician or qualified personnel
who operates the system. The user manual refers to this document as 'Instructions for use'.
Instructions for Use/Additional information:
'Instructions for use' contains all the information required to operate this system in a safe and effective
manner. 'Additional information' is also available to the interested reader. The operator can find these
documents under the help menu in the software. The operator can also refer to these manuals on the
manufacture's official website.
Intended use
VisualEyes™ 505 is a Video Frenzel system that provides information to assist in the evaluation, diagnosis and
documentation of vestibular disorders. This system evaluates nystagmus using a goggle mounted with cameras.
These images are displayed and stored in the software. This information can then be used by a trained medical
professional to assist in diagnosing vestibular disorders. The target patient population for VisualEyes™ 505 is
five years of age and above.
VisualEyes™ 505 is to be used by trained personnel only, such as audiologists, physical therapists, ENT
surgeons, doctors, hearing healthcare professionals or personnel with a similar level of qualifications. The device
should not be used without the necessary knowledge and training to understand its use and how results should
be interpreted.
Contraindications
VisualEyes™ 505 testing may be contrainidicated in patients who exhibit the following: blindness, broken nose
or other face/head trauma, recent eye surgery and ptosis.
Product description
VisualEyes™ 505 is a piece of software that can be configured with a goggle with one or two cameras, which
are connected to a computer to perform the testing. Standard and optional tests are described below (Table
1.4-1).
D-0126472-A – 2020/08
VisualEyes™ 505 Instructions for Use -US
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
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