Defibtech Makes Its First International Shipment of Automated External Defibrillators -AEDs-.Business Editors/Health/Medical Writers GUILFORD, Conn.--(BUSINESS WIRE)--May 25, 2004 CE Marking approval, ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485 certification pave the way for international growth Defibtech today announced the international release of its Lifeline(TM) automated external defibrillators (AEDs), with its first major shipment to a customer in Italy. A leading innovator in the AED AED - Automated Engineering Design market, Defibtech recently paved the way for international sales by gaining CE Marking approval and ISO 13485 certification. Over the next several weeks and months, the company will continue its international rollout of the innovative Lifeline defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a to its distributors in Europe, South America, the Middle East and Asia. The CE Marking is recognized by member countries of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , as well as a number of other countries in Latin America, South America and Asia. The ISO 13485 certification places Defibtech in full quality compliance with European Union (EU) Directives for Medical Devices in the design, production, sales and services for automated external defibrillators (AEDs) and accessories. The certification process included a full quality system audit by an approved Notified Body to the ISO 13485 standard (Quality systems - Medical devices). Featuring industry-leading biphasic bi·pha·sic adj. Having two distinct phases: a biphasic waveform; a biphasic response to a stimulus. defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. technology, the Defibtech AED is the market's most affordable unit, with a single-unit list price of $1,495 in the United States. The device has received several awards, including an Excellence in Design Award in the medical category from Appliance Manufacturer magazine. Easy to use and portable, the Defibtech AED actually "talks" to the user, giving audible step-by-step instructions on how to give lifesaving defibrillation. The AED's bright coloring and award-winning design make it easy to find and operate quickly. Having the industry's longest operational battery life, the Defibtech AED is built to the durability standards of professional emergency personnel. AEDs dramatically improve the chances of surviving sudden cardiac arrest (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. ), which causes the heart to become arrhythmic ar·rhyth·mic adj. Lacking rhythm or regularity of rhythm. and stop pumping blood effectively. The majority of SCA victims receiving timely defibrillation survive; without it, fewer than 5 percent of SCA victims live. AEDs deliver a defibrillating electrical shock that restores the heart's rhythm to normal. More than 400,000 people die from SCA annually. About Defibtech Defibtech relentlessly pursues one goal: making the best automatic external defibrillators (AEDs) in the world at affordable prices. Defibtech designs and manufactures the FDA-approved and CE-Marked Lifeline(TM) and ReviveR(TM) brand AEDs and related accessories. Defibtech's products are sold through its network of distribution partners in the United States and around the world. Founded in 1999, Defibtech is headquartered in Guilford, Conn., and manufactures all of its defibrillators in the United States in a state-of-the-art ISO- iso- or is- pref. 1. Equal; uniform: isobar. 2. Isomeric: isopropyl. 3. 9002 certified facility. For more information about Defibtech and its products, visit www.defibtech.com or call 1-866-DEFIB-4-U (1-866-333-4248). |
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