Instrumentation Difra SA

Address:Industriestrasse 33,Eupen Liege,BE

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- Catalog Number : 22315

Device Description : The Ideas III is an Electronystagmography (ENG) system. Electronystagmography me The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro-oculography (EOG). In this method, skinmounted electrodes measure changes in potentials across the eyeball due to movement of the eye in its socket. The corneal retinal potential is the source of the measured voltage. Those movements are recorded and transmitted to a computer. The eye movement is analyzed by the software.Ideas III is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). Ideas III is able to record horizontal and vertical movements simultaneously on both eyes or on one eye only.

Device Class : 2

Duns Number: 370173410

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

- Catalog Number : 22709

Device Description : The videonystagmography performed by a camera and infra red light measures and r The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.

Device Class : 2

Duns Number: 370173410

Premarket Exempt : Yes

Product Code : GWN

Prescription Use : No

Device Count : 1

Device Description : The air caloric stimulator is a device that delivers a stream of air to the ear The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow 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.The handle is equipped with an otoscope head where a disposable ear tips can be fixed for easy management of hygiene. The otoscope handle provides also a magnifying glass and integrated light to inspect the ear canal and the tympanic membrane without obstructing the stimulation.By default, temperature values are 27°C, 30°C, 44°C and 47°C.Five stimulation times are available: 40, 60, 80,100 and 120sWarm air caloric stimulatorMinimal temperature reachable: 5°C over the ambient temperatureMaximal temperature reachable: 48°CAir flow: fixed, from 10 to 13l/min, without ear tipTimerIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to thecaloric testing process.

Device Class : 1

Duns Number: 370173410

Premarket Exempt : Yes

Product Code : KHH

Prescription Use : No

Device Count : 1

Device Description : The air caloric stimulator is a device that delivers a stream of air to the ear The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow 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.The handle is equipped with an otoscope head where a disposable ear tips can be fixed for easy management of hygiene. The otoscope handle provides also a magnifying glass and integrated light to inspect the ear canal and the tympanic membrane without obstructing the stimulation.By default, temperature values are 27°C, 30°C, 44°C and 47°C.Five stimulation times are available: 40, 60, 80,100 and 120sWarm air caloric stimulatorMinimal temperature reachable: 5°C over the ambient temperatureMaximal temperature reachable: 48°CAir flow: fixed, from 10 to 13l/min, without ear tipTimerIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to thecaloric testing process.

Device Class : 1

Duns Number: 370173410

Premarket Exempt : Yes

Product Code : KHH

Prescription Use : No

Device Count : 1