Press Release Summary:
Catering to medical device manufacturers, MEDIALOG welder meets requirements for ultrasonic assembly processes in sterile environments. Features include stainless steel, cleanroom-compatible surfaces as well as pneumatics and FSC (FDA System Component) operator interface. FSC meets FDA CFR 21 part 11 FDA requirements; includesÂ complete documentation, including all actions performed by authorized users; and records time stamped audit trails.
Original Press Release:
Medical Handle Challenges Tool Design for Joining Sophisticated Ultrasonic Welding Application Solved
Herrmann Ultrasonics Inc., Bartlett, IL, has worked with medical company Genicon, in Winter Park, FL, to build one of the largest ultrasonic medical weld tools ever designed. The product being welded – a newly designed suction irrigation handle – which was shown by Genicon at the recent MEDICA 2015 tradeshow in Germany. The device in its entirety is used for liposuction. Due to the size of the joining partners and their three dimensional shape this application was very challenging – especially the 12 mm difference in contour heights which needed to be matched by the contact surface of the weld tool, called sonotrode. The team at Herrmann made it work with a 220x180mm aluminum sonotrode.
To meet the increasing requirements for ultrasonic assembly processes in sterile environments, Herrmann Ultrasonics has introduced the new MEDIALOG welder, which caters to medical device manufacturers. Together with stainless steel, cleanroom-friendly surfaces and modified pneumatics the MEDIALOG includes the unique operator interface FSC. This stands for FDA System Component and meets the demanding requirements FDA CFR 21 part 11 of the Food and Drug Administration. FSC includes a complete documentation all actions performed by authorized users and records time stamped audit trails. The creation of customized individual access authorization in combination with electronic signatures ensures authenticity, completeness and confidentiality of all data.
Visit us in booth # 3141 during the MD&M WEST 2016 (Feb. 9 – 11, 2016) to see the HiQ MEDIALOG and to find out more details about ultrasonic welding!