Acertara Announces Its TEE Repair Processes Validated by CS Medical
LONGMONT, Colorado– Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2016 certified probe repair and new product development facility, announces that its TEE probe repair processes have been validated by automated TEE reprocessor, CS Medical’s laboratory and engineering team. This testing process included more than 1,000 cleaning & high-level disinfection cycles, electrical leakage testing, and rigorous visual inspections. CS Medical’s TEEClean Automated Cleaner Disinfector is the gold standard in the automated reprocessing device industry with the TEEClean being the only automated cleaner and disinfector for TEE probes in the United States.
Acertara is the only TEE probe repair company whose repair processes have been independently validated by CS Medical. Commenting on this, Acertara CEO G. Wayne Moore said; “Acertara is the industry leading technology-based company in the probe repair market and we partner with other industry leading companies to ensure that every ISO13485:2016 certified probe repair procedure we develop results in a safe and effective outcome that returns the probe to substantial equivalence to a new OEM probe.”
Mark Leath, President of CS Medical agrees, saying: “Acertara, to date, is the only probe repair company in the industry that has been tested using our automated cleaner disinfector. The test method is real-time and is actual cycle for cycle testing to clean and disinfect a TEE ultrasound probe. Our scientists and engineers have concluded that the repair work done by Acertara will effectively pass continued reprocessing by healthcare professionals. A probe repaired by Acertara and reprocessed with one of CS Medical’s automated cleaner disinfectors should provide confidence for the organization and safety for the patient.”
Acertara Acoustic Laboratories, 1950 Lefthand Creek Lane, Longmont, Colorado 80501 is an ISO/IEC 17025:2017 accredited acoustic measurement laboratory and ISO13485:2016 ultrasound probe repair facility providing acoustic power testing services to ultrasound OEMs and regulatory bodies around the world, new product development, and advanced probe repair. Additional information about Acertara can be found on its Website www.acertaralabs.com
About CS Medical LLC: CS Medical, LLC, has pioneered the automated cleaning and disinfection process for Transesophageal ultrasound probes since 2005. In 2005, the TD 100® was the first FDA cleared automated disinfection process with printed verification for transesophageal (TEE) ultrasound probes. In 2019, the clearance and release of TEEClean® provided healthcare professionals with a safe, reliable, and confident automated method for complete TEE ultrasound probe reprocessing. TEEClean provides an FDA validated cleaning and disinfection process. The soiled TEE probe receives enzymatic cleaning with TEEZyme® for TEEClean followed by either TD‑5® or TD‑8® for high-level disinfection. Both processes are completed automatically within TEEClean and the TEE probe is thoroughly rinsed at the conclusion of the disinfection cycle. An electronic record and a printed verification report are generated at the conclusion of each cycle. The verification report indicates probe contact time with the cleaner and high-level disinfectant as well as the average temperature of the cleaner and single-use disinfectant during each cycle. www.csmedicalllc.com