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1
Device description
The ICS Aircal® Air Caloric Irrigator is a convenient and accurate air caloric stimulator to be used for evoking nystagmus
during VNG/ENG examinations. The device provides thermal stimulation through the use of a carefully controlled
flow of air. The air temperature is adjustable from 12°C to 50°C. The system provides for presetting two temperatures
-- one for the warm and one for the cool caloric stimulation. Precise temperature control is maintained through the
use of a thermistor located close to the point of airflow delivery. The innovative design of the otoscopic delivery
head allows observation of the point of stimulation, assuring valid and repeatable responses.
1.1
Intended use
An air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of airflow and
temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular
stimulation of the semicircular canals produces involuntary eye movements that are measured and recorded by a
nystagmograph.
1.2
Intended users and patient target group
The ICS Aircal system is to be used only by qualified medical personnel with prior knowledge of the medical and
scientific facts underlying the procedure.
The ICS Aircal system is intended for patients of all ages who can tolerate testing.
1.3
Clinical benefits
The caloric test is a conventional clinical procedure that involves the clinician directing warm and cool air or water
into the patient's ear canal for a given period of time; the resultant eye movements are measured and analyzed.
Caloric testing is performed initially without fixation, and then fixation is provided at a given period of time following
the end of the stimulus presentation. These tests are designed to be part of a battery of vestibular tests to aid in
differential diagnosis.
1.4
Contraindications and side effects
Do not perform irrigation on patients with tympanic membrane perforations.
1.5
Typographical conventions
Use of Warning, Caution, and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses
pre-cautionary statements as follows:
Warning
with the use or misuse of the device.
Caution • Indicates that there is a possibility of a problem with the device associated with its use or
misuse. Such problems include device malfunction, device failure, damage to the device, or damage to
other property.
Note
Indicates that you should take special notice.
•
ICS Aircal
Indicates that there is a possibility of injury, death, or other serious adverse reactions associated
•
Device description
5
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