Creedmoor, NC-- CS Medical, LLC is pleased to announce receiving CE Marking approval for the TD 100® automated transesophageal echocardiogram (TEE/TOE) probe disinfector and TD-8® OPA based high-level disinfectant. The TD 100 with TD-8 provides high-level disinfection of TEE/TOE probes in 5 minutes.
"We are extremely excited to become the first TEE/TOE automated probe disinfector to have medical device clearances in both North America and Europe. The advantages of automated reprocessing, which North American customers’ have seen for over ten years, can now be experienced in Europe. This will provide healthcare professionals confidence in the reprocessing of TEE/TOE probes," said Mark Leath, CS Medical President.
In developing the TD 100, CS Medical pioneered the automated disinfection process for TEE/TOE probes. The TD 100 established the first FDA cleared TEE/TOE ultrasound probe automated disinfection process with printed verification and now is the first TEE/TOE probe automated disinfector to have cleared both FDA and Directive 93/42/EEC.
During the disinfection process, the TEE/TOE probe completes high-level disinfection in five minutes, followed by five complete rinse cycles before disinfection confirmation is acknowledged and a report is printed. The TD 100 automated TEE/TOE probe disinfector eliminates manual reprocessing of delicate and expensive TEE/TOE ultrasound probes while providing a repeatable and validated disinfection process.
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.