Instrumentation Difra

Basic Information

• Brand Name: Instrumentation Difra
• Primary DI: B51617553
• Version / Model: CoolStar 115V 3.0
• Catalog Number: 17553
• Company Name: Instrumentation Difra SA
• Labeler DUNS: 370173410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 6e18f423-a3b8-4ef8-963d-b33310a5a009

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 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	874.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34891	Diagnostic caloric vestibular stimulation system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B51617553	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	11.5	Centimeter
Length	31	Centimeter
Depth	45.5	Centimeter
Weight	5	Kilogram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity