Instrumentation Difra

Primary DI
B516175500
Brand
Instrumentation Difra
Company
Instrumentation Difra SA
Model
AquaStar 115V 2.0
Catalog number
17550
Device description
The water caloric stimulator is a device that delivers a stream of water 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.An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60sBy default, temperature values are 27°C, 30°C, 37°C and 44°C.Minimal temperature reachable: 3°C over the ambient temperatureMaximal temperature reachable: 48°CWater flow: fixed, 350ml/minTimerRequires a water supply and an outletIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to thecaloric testing process.
Published
2020-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETPStimulator, Caloric-Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETPStimulator, Caloric-WaterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B516175500PrimaryHIBCC0

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
Depth35.5Centimeter
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
Primary DIBrandModelCatalogPublished
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B516326290Instrumentation Difra SAHeadStar V3.0326292025-03-12
B516326380Instrumentation Difra SAHeadStar V3.0326382025-03-12
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B516223150Instrumentation DifraIdeas III223152021-06-28
B516174730Instrumentation DifraAquaStar 230V 2.0174732020-05-18
B516174810Instrumentation DifraCoolStar 230V 3.0174812020-05-18
B516174850Instrumentation DifraAirStar 2.0174852020-05-18
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
B51617553Instrumentation DifraCoolStar 115V 3.0175532018-09-17
B516220900Instrumentation DifraVIDEOSTAR220902020-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250365142273ATMOSATMOS MedizinTechnik GmbH & Co. KGETP2024-11-27
04250365142297ATMOSATMOS MedizinTechnik GmbH & Co. KGETP2024-11-27
05711117199574InteracousticsInteracoustics A/SETP2022-04-12
B516174730Instrumentation DifraInstrumentation Difra SAETP2020-05-18
B51617473Instrumentation DifraInstrumentation Difra SAETP2018-09-17
B51617550Instrumentation DifraInstrumentation Difra SAETP2018-09-17