Unique innovation cleared for cleaning and disinfecting TEE ultrasound probes
CS Medical has announced the clearance of a new Class II medical device by the Food and Drug Administration. The company says the TEEClean Automated TEE Probe Cleaner Disinfector is the first medical device cleared in North America which provides both cleaning and high-level disinfection of a TEE ultrasound probe.
“The healthcare professional simply places a bedside cleaned TEE probe into TEEClean and follows simple prompts on the color touchscreen display,” said the CS Medical in a news release. TEEClean guides the healthcare professional through an FDA-validated workflow for effective reprocessing of soiled TEE probes and electronic record retention has the ability to store more than 15,000 sessions in system memory.
The user interface allows data entry through a scanner or manual keypad entry on the large 7 inch color LCD touchscreen. TEEClean utilizes the same disinfection technology as the TD 100. TD 5 or TD 8 high-level disinfectants can be used in TEEClean while the cleaning is completed with TEEZyme enzymatic detergent. TEEClean utilizes the same advanced vapor management system as the TD 100 and incorporates a new, high quality water filtration system through an FDA registered Class II device. TEEClean rinses each TEE probe with a 5 nanometer (.005 micron) water filter that retains bacteria, viruses, and endotoxins.
“Today’s news marks the next era in the reprocessing of TEE ultrasound probes, cleaning, and disinfection within one machine, an automated TEE ultrasound reprocessor,” said Mark Leath, CS Medical President in the statement. “TEEClean is the combination of years of research, development, and commitment by our entire staff.”
