f41d105f-d882-42e9-9b08-a85dea04dd96UpdatePublished22020-11-192018-09-17In Commercial DistributionB51617485PrimaryHIBCCInstrumentation DifraAirStar 2.017485370173410Instrumentation Difra SA1The 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 120s Warm air caloric stimulator Minimal temperature reachable: 5°C over the ambient temperature Maximal temperature reachable: 48°C Air flow: fixed, from 10 to 13l/min, without ear tip Timer Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process.falsetruefalsefalsefalsefalsefalsetruefalsefalsefalsetruefalseLabeling does not contain MRI Safety Informationfalsefalse260.436.1436dbscherer@gmail.com34891Diagnostic caloric vestibular stimulation systemAn assembly of devices intended to evaluate a patient’s vestibular function through the application of heat and/or cold stimuli in the form of a stream of air or water into the ear canal, whereby involuntary horizontal eye movements (nystagmus) are produced and measured using a nystagmograph. The procedure may also be referred to as caloric reflex test, and is typically used for assessing a patient's balance system and/or to test for brainstem death. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. This device is typically used in an ear/nose/throat (ENT) department.falseActiveKHHStimulator, Caloric-AirDepthLengthHeightWeightHandling Environment TemperatureStorage Environment TemperatureStorage Environment HumidityHandling Environment Humidityfalsefalse