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…
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 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.
Who Else Makes It
Registered in Beijing.
Record
Regulatory record for Instrumentation Difra SA | Listed by | Instrumentation Difra SA |
| FDA product code | KHH |
| Device type | Stimulator, Caloric-Air |
| Device class | Class 1 |
| Regulation | 21 CFR 874.1800 |
| Premarket notification | Exempt |
| Record published | 2022-09-28 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
| Storage | Handling environment temperature 5 to 35 °C; Storage environment temperature 5 to 55 °C; Storage environment humidity 30 to 90 % RH; Handling environment humidity 30 to 90 % RH |
| Sizes | Depth 34.5 cm; length 31 cm; height 11.5 cm; weight 5 kg |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.