FDA Provides Clearance For New Patient Monitoring System
Kingsport, Tenn. Aug. 23, 2012 The ViSi Mobile® System, a continuous vital signs monitoring device produced by Sotera Wireless, Inc. that uses Eastman Chemical Companys Tritan" copolyester has received 510(k) clearance from the United States Food and Drug Administration (FDA). The device is now available commercially for hospital use. The monitoring systems lens, housing and connectors are made with Tritan, a new-generation copolyester that has a balance of properties, including toughness and chemical resistance.
The small, wrist-worn ViSi Mobile System was developed specifically for ambulatory patients on
non-Intensive Care Unit areas to help detect early changes in a patients condition and prevent adverse events. It measures and displays all core vital signs including heart and pulse rate, blood pressure, oxygen saturation and skin temperature while maintaining monitoring when a patient is being transported and allowing the patient the ability to move about the hospital.
We knew that a device capable of tracking patients vitals without limiting them to the confines of their hospital room would need to address a wide range of hospital situations, said Gunnar Trommer,
vice president, marketing and customer service, Sotera Wireless, Inc. The ongoing interaction with the experts at Eastman helped ensure that our monitoring system is using a material that is not only durable but also can be treated with chemicals used in hospital-grade disinfectants and cleansers without cracking or crazing.
Using Eastman Tritan" copolyester for the ViSi Mobile System provided the durability and the impact and chemical resistance necessary for such a device. These devices require such qualities because they are repeatedly used and can be dropped or damaged, and they also are frequently cleaned with strong disinfectants and chemicals.
In addition to the benefits it brings to the end product, Eastman Tritan" copolyester also has design flexibility and processing benefits. The cold-swaging ability of Tritan allowed for the fit and press assembly of the ViSi Mobile System, creating a tight, smooth, continuous fit between parts. This process allows for the parts to be joined without chemicals, adhesives or mechanical fasteners.
Advancements in wireless patient monitors such as the ViSi Mobile System are helping meet the health-care needs of an aging population while allowing patients to maintain a sense of freedom. Wireless patient monitors have experienced significant growth in recent years, a trend that is forecasted to continue over the next several years.
The health-care industry understands the value of durable, reliable wireless devices that enhance patient safety and comfort, said Gopal Saraiya, global segment leader, medical devices, Eastman. Contemporary plastic materials, such as Eastman Tritan copolyester, are well-positioned to meet the demand for continued innovation in the development of these wireless products.
For more information on Eastman Tritan" copolyester, visit www.eastman.com/tritan.
For more information about the ViSi Mobile® System and to watch videos about the device, visit www.visimobile.com. The ViSi Mobile System is FDA cleared for monitoring of electrocardiograms, heart rate/pulse rate, blood oxygen saturation level, respiration rate, noninvasive blood pressure and skin temperature.