CS Medical announces FDA 510(k) clearance of the TD 100®

CS Medical announces FDA 510(k) clearance of the TD 100®

The TD 100 is an automated disinfector designed to reduce the manual manipulation, complexity and length of time required to properly disinfect transesophageal (TEE) ultrasound probes. Utilizing a microprocessor controller, the TD 100 provides a simple user interface that guides the technician through the few steps of the high-level disinfection that require user input. Once initiated, the disinfection process continues automatically and alerts the technician at the end of the 17-minute cycle. The TD 100 eliminates the need for manual reprocessing, thereby saving time and providing printed verification of probe disinfection.

″The TD 100 is the first automated TEE disinfector on the market, and represents a significant step forward in disinfection technology,″ said Greg Dobbyn, CEO of CS Medical. ″Endoscope technicians have enjoyed this type of automated disinfection for a while now, and we've brought this same convenience and time savings to anyone tasked with handling and cleaning TEE probes.″

The TD 100 is the first and only automated TEE disinfector available in North America, and has received 510(k) clearance from the FDA.

Read more about the TD 100.


About CS Medical

CS Medical LLC has pioneered the automated disinfection process for Transesophageal ultrasound probes with the development and release of the TD 100® Automated TEE Probe Disinfector. In 2005, the TD 100 was the first FDA cleared automated disinfection process with printed verification for Transesophageal ultrasound probes. During the disinfection process, the TEE probe receives high-level disinfection in (5) five minutes from TD-5® or TD-8® followed by (5) five complete rinse cycles before disinfection confirmation is acknowledged and a report is printed. The verification report indicates probe contact time with the high-level disinfectant as well as the average temperature of the single-use disinfectant during each cycle.

For more than 15 years and over 4 million high-level disinfections, the TD 100 Automated TEE Probe Disinfector has eliminated manual reprocessing of delicate and expensive TEE ultrasound probes while also providing a repeatable and FDA cleared disinfection process. The TEEClean® Automated TEE Probe Cleaner Disinfector will continue the TD 100's work by automating the required cleaning process for the TEE probe before high-level disinfection. TEEClean, with electronic record data logging, printed verification reporting, FDA cleared cleaning, and high-level disinfection will be the standard of care for TEE ultrasound probes.

CS Medical's TEE Complete Care® products provide quality device care and storage by minimizing healthcare operational costs, improving service readiness and increasing regulatory compliance.

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