PCI Medical Announces FDA 510(k) Clearance for ASTRA VR and ASTRA TEE Automated Reprocessors for Endovaginal/Endorectal Probes and TEE Ultrasound Probes
Deep River, Connecticut – PCI Medical is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration for the ASTRA VR and ASTRA TEE automated reprocessors used to facilitate the high-level disinfection of endocavity ultrasound probes.
"The ASTRA VR and ASTRA TEE automated reprocessors are the next innovation in ultrasound probe disinfection," stated Philip Coles, Founder and Chairman of PCI Medical. "For over 20 years PCI Medical has developed high-level disinfection systems for ultrasound probes to help keep patients and probes safe, while saving our customers money. The ASTRA series automatically controls the time, temperature and rinse cycles for the probes while providing fully automated data logging."
The ASTRA VR is an automated reprocessor for the high-level disinfection and rinsing of one or two endovaginal/endorectal ultrasound probes. The ASTRA TEE is an automated reprocessor for the high-level disinfection and rinsing of one or two transesophageal (TEE) probes.
The ASTRA® series of automated reprocessors offer many unique features that help users meet audit and accreditation requirements for Joint Commission and Infection Control standards. The ASTRA uses a reusable, industry standard high-level disinfectant that dramatically minimizes cycle costs. A single gallon of disinfectant can be reused in the system for up to 14 days. A built-in bar code reader captures and automatically stores information including: type of disinfectant, probe ID and operator ID. The ASTRA also automatically captures and logs temperature, date and time of disinfection, MRC pass or fail and cycle outcome. All of the data from the last 1,000 cycles is stored on the ASTRA and downloaded via a USB port as needed.
For more information on the ASTRA series of automated reprocessors, go to www.pcimedical.com/astra/
About PCI Medical - Experts in High-Level Disinfection®
For over 20 years, PCI Medical has developed and manufactured high-level disinfection systems. PCI Medical manufactures a complete line of GUS® manual soak stations as well as Storage Systems for endovaginal/endorectal, general purpose probes and TEE probes, and other accessories for high-level disinfection such as spill kits and neutralizers. GUS Disinfection Soak Stations are used in over 6,000 facilities throughout the US and Canada.
In addition to our quality products, the PCI Medical Disinfection Team helps facilities to become or stay compliant in the high-level disinfection process, from pre-cleaning through to storage. We are Experts in High-Level Disinfection.
For more information about PCI Medical products and educational offerings, please visit www.pcimedical.com