New Matrix 8000 Scanning System

For Immediate Release
July 24, 2006

Introducing The NEW Matrix 8000 Scanning System
Automatic Medical Device Testing to IEC 60601-1 Industry's First Modular Configuration – Customizable by Application

Maynard, MA - QuadTech, maker of test and measurement equipment, electrical safety test and passive component measurement solutions, proudly announces the release of the most innovative electrical safety test system available on the market. The new Matrix 8000 Scanning System, the key component of QuadTech’s Medical Electrical Safety Test System puts hardware flexibility in the Medical Manufacturer’s hands. Dramatically reduce the number of test and measurement equipment, test processes and operator involvement by using test modules configured to your specific product. Improve compliance with QSR ISO13485 and FDA’s 21 CFR 820, and incorporates lean manufacturing benefits in your manufacturing processes.

The Matrix 8000 Scanning System consists of an 8-slot Master unit configurable with 4-point Module Cards for a 32-point test matrix. The scalable configuration of the Matrix 8000 allows for future system expansion with the capability of adding up to 8 Slave units for a total of 288 test points. Mix and match the test points by selecting module cards for DUT Power, Ground Bond, AC/DC Hipot, Leakage Current and F-Type Leakage Current Testing. Customize your product testing and increase the number of test channels for multi-point or multi-device testing by selecting the module cards applicable to your product.

Some of the outstanding features which make the Matrix 8000 Scanning System an integral part in the Electrical Safety Testing of Medical Devices:
• Automated IEC 60601-1 and IEC 60601-2-XX Testing
• Modular Configuration – Expandable to 288 Test Points
• Customize Matrix Scan unit with Module Cards
• Power Up/Down Device with Software
• Scan Measurements without shutting off power
• Multiple Patient Connections
• Test Defib-Proof Applied Parts
• Test Multiple Products Simultaneously
• Ground Bond, DUT Power, AC/DC Hipot Testing
• Earth, Enclosure, Patient & Patient Auxiliary Leakage Testing
• F-Type (Mains on Applied Part) Leakage Testing
• USB, IEEE and RS-232 Communication

The Matrix 8000 Scanning System combined with the Guardian 6100 Plus Electrical Safety Test Analyzer and an AC source is a complete electrical safety test system allowing medical device manufacturers to fully comply with the test requirements of IEC 60601-1 and the particular standards IEC 60601-2-XX. Perform Earth, Enclosure, Patient, Patient Auxiliary and F-Type (Mains on Applied Part) Leakage Current measurements. The Leakage Current mode has a 20A input current capability. Tests performed under normal conditions, reverse power line or fault conditions, open ground and open neutral are implemented automatically by the system without operator intervention.

QuadTech’s test and measurement equipment and Electrical Safety Test Systems are driven by the new CaptivATE software to fully automate medical device testing. Create a global database for traceability of raw test data. Print test reports on demand. Filter and plot test data to analyze historical trends. Achieve paperless testing and create electronic signatures for compliance with Regulatory Agencies.

To support a variety of measurement applications, QuadTech offers a large selection of accessories for its Electrical Safety Test Systems, including AC Sources, test leads, adapters for connecting to 115V/220V corded products, line isolation transformers and more. In addition, QuadTech provides product training and industry seminars.

Available June 2006, QuadTech’s Electrical Safety Test Systems are specified on a per Customer basis after an engineering consultation of the customer’s current & future test requirements and review of his current test instruments, processes and procedures. System training, installation and validation are also performed by QuadTech.

About QuadTech:
QuadTech, an ISO 9001-Registered company, is a test and measurement equipment, medical device testing and electrical safety test solutions provider enabling Medical Device Manufacturers and other manufacturing industries to test the safety and quality of their electrical products while ensuring compliance to FDA and other regulatory agencies. QuadTech offers a complete line of instrumentation and solutions including LCR meters, hipot and ground bond testers, safety analyzers, megohmmeters, milliohmmeters, systems and software, as well as calibration and repair services. Based in Marlborough, MA, QuadTech has a worldwide network of direct sales and distributors who service and support customers. QuadTech is dedicated to doing everything in its power to assist the customer in achieving their testing objectives.