Interacoustics VN415 - Intended Use

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 1
Intended Use
The two Interacoustics VNG systems, VN415 and VO425, are primarily intended for use in the
evaluation, documentation and diagnosis of vestibular disorders. This is of particular interest to Ear,
Nose and Throat specialists, to Neurology specialists, Audiology specialists and other health care
professions concerned with balance assessment. The VN415 is the basic unit for peripheral vestibular
testing and the VO425 is the extended system for central testing using oculomotor stimuli.
Precautions
1. It is recommended that parts which are in direct contact with the patient (e.g. disposable
goggle foam pads) should only be used with one patient, and should therefore be discarded
after each session.
2. Please note that the CE Marking is only legal if this Instruction is translated into the national
language of the user no later than at the delivery to him, if the national legislation demands a
text in the national language according to MDD article 4.4.
3. Please note that if connection is made to standard equipment like printers and network,
special precautions must be taken in order to maintain medical safety.
4. Although the instrument fulfils the relevant EMC requirements precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the
device is used adjacent to other equipment it must be observed that no mutual disturbance
appears.
If this apparatus is connected to one or more other devices with medical CE marking,
to make up a system or pack, the CE marking is only valid also for the combination if
the supplier has issued a declaration stating that the requirements in the Medical
Device Directive article 12 are fulfilled for the combination.
Operation Instructions
Preparations prior to the VNG Test
To ensure reliable and valid test results from your VN415 / VO425 it is important that the patient is
prepared for the test.
Preparation of the patient
No glasses or contact lenses should be worn during the examination. Eye makeup should also be
removed, as this may disrupt the registration of the pupil. Finally, the patient should have received
instructions to discontinue any form of non life sustaining medication prior to the examination.
WARNING indicates a hazardous situation which, if not avoided, could result
in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in minor or moderate injury.
NOTICE is used to address practices not related to personal injury.