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Cardiac Science Receives ISO 9002 and CE Certification.


IRVINE, Calif.--(BW HealthWire)--July 8, 1998--Cardiac Science Inc. (OTC/BB:DFIB), developer of the Powerheart(R) Automatic External Cardioverter Defibrillator (AECD AECD Automatic external cardioverter-defibrillator A device that monitors cardiac rhythm and automatically defibrillates (R)) technology, has received certification to the 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.
 9002 quality standard as well as the European Union's Medical Devices Directive
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 (MDD MDD Major depressive disorder, see there ).

TUV (Technischer Überwachungs-Verein) Literally "Technical Watch-Over Association." A German certifying body involved with product safety for the European community.  Product Services served as the company's registrar and Notified Body in conducting the certification audit. MDD certification allows the company to legally affix the CE Marking to offer its products for sale in the European Community and European Economic area European Economic Area: see European Free Trade Association; European Union. . The CE Marking is required for sales into these markets after June 14, 1998.

The ISO 9002 quality standard involves all operational areas of the business including sales, contract management, engineering, manufacturing, quality assurance, test, service, and customer support. Maintaining certification to the ISO 9002 standard requires continuous improvement of processes aimed at achieving total customer satisfaction. Registration to ISO 9002 validates Cardiac Science's conformance with the standards set by the International Organization for Standardization International Organization for Standardization (ISO)

Organization for determining standards in most technical and nontechnical fields. Founded in Geneva in 1947, its membership includes more than 100 countries.
. Over 90 countries around the world have adopted the ISO 9000 series of standards.

"This is a major achievement for Cardiac Science and all of its employees. Without strong employee participation, this could not have happened" said Raymond W. Cohen cohen
 or kohen

(Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male.
, president & chief executive officer. "ISO 9002 certification not only provides a significant impetus to our internal operations, but it also is highly recognized in the marketplace, particularly internationally. International customers often require ISO 9000 certification as a precondition to be qualified as a supplier."

Using its proprietary tachyarrhythmia tachyarrhythmia /tachy·ar·rhyth·mia/ (tak?e-ah-rith´me-ah) any disturbance of the heart rhythm in which the heart rate is abnormally increased.

tach·y·ar·rhyth·mi·a
n.
 software technology platform, Cardiac Science developed the Powerheart Automatic External Cardioverter Defibrillator. The Powerheart(R), a non-invasive bedside defibrillator used to continuously monitor hospitalized cardiac patients for life-threatening heart rhythms, delivers 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.
 shocks within seconds and without human intervention should a patient suffer cardiac arrest.

The Powerheart AECD(R), in controlled multi-center clinical studies, demonstrated a sensitivity of 100 percent (correctly identifying shockable episodes), a specificity of 99.4 percent (not allowing a non-shockable rhythm to be shocked), first shock efficacy of 96.2 percent with energy levels as low as 50 joules and an average response time of 21 seconds, indicating that it is an accurate and reliable tool in helping to save people from in-hospital cardiac arrest.

Cardiac Science, through its subsidiary Diagnostic Monitoring, manufactures Ambulatory Holter ECG ECG electrocardiogram.

ECG
abbr.
1. electrocardiogram

2. electrocardiograph


ECG
Also called an electrocardiogram, it records the electrical activity of the heart.
 recorders and Holter systems and distributes these products in the United States and in over 40 countries. For more information, visit the company's Web sites at www.cardiacscience.com and www.diagnosticmonitoring.com.

This news release contains forward-looking statements, including but not limited to those regarding Cardiac Science's ability to improve patient-care, increase survival rates for in-hospital cardiac arrest victims, and reduce patient care costs. Actual results could vary materially from the description contained herein due to many factors, including hospital operations, market and clinical users' acceptance of new and existing products, impact of competitive products and pricing, changing market conditions, and risks detailed in the company's Form 10-KSB for the year ending Dec. 31, 1997 and other documents filed with the Securities and Exchange Commission. The company does not undertake any obligation to update the information contained herein, which speaks only as of this date. The Powerheart(R) and AECD(R) are registered trademarks of Cardiac Science Inc.

    CONTACT:  Cardiac Science Inc., Irvine
               Brett Scott, Chief Financial Officer
               Stan Tillman, Director of Quality Assurance &
               Regulatory Affairs
               949/587-0357


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Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Article
Geographic Code:1USA
Date:Jul 8, 1998
Words:556
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