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 tip 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. CoolStar is ideal when water can not be used for stimulation (tympanic membrane perforation, …), when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22°C. Cool and warm air caloric stimulator Minimal temperature reachable: 10°C with water temperature in glass jar below 50°C Maximal temperature reachable: 49,8°C Air flow: fixed, from 8 to 10l/min, without ear tip Timer: Five stimulation times are available: 40, 60, 80,100 and 120s Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. Glass jar with connection for demineralized water, holder and connections
Who Else Makes It
Registered in Beijing.
Record
Regulatory record for Instrumentation Difra | 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 | 2020-05-18 |
| Record revised | 2020-11-19 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 90 % RH; Handling environment humidity 30 to 90 % RH; Storage environment temperature 5 to 55 °C; Handling environment temperature 5 to 35 °C |
| Sizes | Height 11.5 cm; depth 34.5 to 45.5 cm; length 31 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.