D-0128226-A – 2020/12
Air Fx Caloric Irrigator – Instructions for Use - US
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Introduction
1.1 About this manual
This manual is valid for the Air Fx Caloric Irrigator.
Manufacturer:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel. :
+45 6371 3555
Fax:
+45 6371 3522
E-mail:
info@interacoustics. com
Web:
1.2 Intended use
The Air Fx air irrigator dispenses cool or warm air to perform caloric tests for vestibular diagnosis. The Air Fx
requires the operator to aim the air stream at the tympanic membrane through the patient’s ear canal,
creating a differential in ear temperatures and resulting in the patient’s eyes displaying nystagmus. Typically,
four irrigations are performed, a cool and a warm for each ear. Responses to the irrigation are then
compared to determine if one ear motion sensor is weaker than the other ear sensor.
The Air Fx can be used in conjunction with the Interacoustics VN415, VO425, VisualEyes 515, and
VisualEyes 525 VNG/ENG software and Micromedical Spectrum VNG via USB. When integrated with one of
the aforementioned software programs, use of the Air Fx irrigator will start the caloric test with the correct
irrigation temperature.
All personnel who operate the Air Fx should familiarize themselves with the contents of this manual prior to
using the Air Fx with a patient. Additional training can be requested via Interacoustics or one of their sales
representatives.
Air Fx should be used for irrigating the external ear canal only for the purposes of caloric stimulation as a
part of VNG/ENG test protocol. The device is not intended for clearing ear wax.
The otoscope handle uses disposable specula and has an integrated LED, which lights the eardrum without
obstructing the air flow or view of the ear canal. The otoscope handle has a magnifying glass designed to
improve visibility of the tympanic membrane.
If service is required, please contact Interacoustics or the local Interacoustics distributor.
The intended use of this product is for irrigation of the patient’s external auditory canal with either warm or
cool air for the purpose of assessing the peripheral vestibular system. The product is intended to be used by
a trained professional in a clinic, hospital, or rehab setting. The appropriate patient population includes
children and adults with normal external auditory canal and middle ear anatomy.
Contraindication:
Do not perform irrigation on patients with tympanic membrane perforations
