Instrumentation Difra

Primary DI
B51617553
Brand
Instrumentation Difra
Company
Instrumentation Difra SA
Model
CoolStar 115V 3.0
Catalog number
17553
Device description
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 stimulatorMinimal temperature reachable: 10°C with water temperature in glass jar below 50°CMaximal temperature reachable: 49,8°CAir flow: fixed, from 8 to 10l/min, without ear tipTimer: Five stimulation times are available: 40, 60, 80,100 and 120sIntended 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
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KHHStimulator, Caloric-Air

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHHStimulator, Caloric-AirEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B51617553PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Caloric vestibular-stimulation systemAn assembly of devices intended to apply heat stimuli in the form of a stream of air or water into the ear canal. 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. The stimulation of the semicircular canal produces involuntary eye movements (nystagmus) which are measured using a nystagmograph. It is used for vestibular function testing for assessing the patient's balance system. This device is typically used in an ear/nose/throat (ENT) department.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth45.5Centimeter
Height11.5Centimeter
Length31Centimeter
Weight5Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
260.436.1436dbscherer@gmail.com

Regulatory Flags#

DUNS number
370173410
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B516175530Instrumentation DifraCoolStar 115V 3.0175532020-05-18
B51617473Instrumentation DifraAquaStar 230V 2.0174732018-09-17
B51617481Instrumentation DifraCoolStar 230V 3.0174812018-09-17
B51617485Instrumentation DifraAirStar 2.0174852018-09-17
B51617550Instrumentation DifraAquaStar 115V 2.0175502018-09-17
B516220900Instrumentation DifraVIDEOSTAR220902020-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250365143065ATMOSATMOS MedizinTechnik GmbH & Co. KGKHH2024-11-27
B516310120Instrumentation Difra SAInstrumentation Difra SAKHH2022-09-28
B516310130Instrumentation Difra SAInstrumentation Difra SAKHH2022-09-28
05713315009235ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009242ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009259ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009266ICSNatus Medical Denmark ApSKHH2021-07-06
05711117199567InteracousticsInteracoustics A/SKHH2021-06-14
B516174810Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
B516174850Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
B516175530Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
05713315002533GN Otometrics A/SNatus Medical Denmark ApSKHH2019-04-24
B51617481Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
B51617485Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
05713315004124GN Otometrics A/SNatus Medical Denmark ApSKHH2016-09-19
05713315004131GN Otometrics A/SNatus Medical Denmark ApSKHH2016-09-19