QuadTech-Newsletter-Medical-Fall-2007

The MD&M Minneapolis 2007 Conference is a resource event for medical device and equipment manufacturers. QuadTech will be exhiting its Sentinel System October 17-18, 2007 at Booth #1434.

The Sentinel System was designed specifically to address the electrical safety testing needs of Medical Device Manufacturers (MDMs). QuadTech has a dedicated team of professionals who focus exclusively on the needs of Medical Device Manufacturers (MDMs) and possess in-depth knowledge of medical applications. This team, which is comprised of individuals who are experts in IEC 60601 testing processes and MDM manufacturing, will be available during the MD&M Minnesota show to share their knowledge of the industry and discuss how QuadTech’s Sentinel System Solution is impacting MDMs.

A key driver for the future of testing is automation. Automating the testing process enables MDMs to collaborate on a global level, keep production costs down, collect data electronically, improve compliance with global regulatory requirements such as IEC60601-1, and improve the overall efficiency of manufacturing processes. President and CEO, Phil Harris says, “QuadTech continues to focus on the development and enhancement of electrical safety testing solutions for the medical community.”

Shari Richardson, EST Product Manager for QuadTech, will be presenting a paper at the 2007 IEEE Symposium on Product Compliance Engineering being held October 22-23, 2007 in Denver, CO. Please find the paper abstract below.

Calculating the Current Limits to Use in Production Line Dielectric Withstand Tests

For Dielectric Withstand tests, the test standards specify the voltage and the time requirement. In regard to current limits, however, the standards must be vague. Each product has a unique impedance. Therefore, in determining whether a DUT passes or fails, a standard can say only, “each product shall withstand without electrical breakdown.” Two questions must be addressed by the production line QA manager: 1) What does the term “breakdown” mean? 2) How to calculate the settings for the current limits on a programmable tester?

This article includes the result of a survey as to what the term “breakdown” means, and provides a working definition of the term. Next, the article proposes two methods for determining the impedance of a product: sampling and/or using the number provided by the design engineers. To make the process smoother, we suggest, the design engineers should run test samples of impedance in the design phase. The results can be entered in the design specs, which the production line QA people can then refer to.

For more information on this article, please email info@quadtech.com.

OEM New England showcases new advances in design and manufacturing in areas like automation, and engineering. The event being held in Boston, MA at the Boston Convention and Exposition Center, is co-located with NEPCON, the northeast’s event for electronics manufacturing, and Assembly New England, an event dedicated to the entire assembly process.

QuadTech will be exhibiting its Sentinel System and CaptivATE automation software at OEM. Members of QuadTech's Medical Team will be on hand throughout the event. This team is comprised of individuals who are experts in IEC 60601 testing processes and MDM manufacturing, and will be available during the OEM New England event to share their knowledge of the industry and discuss how QuadTech’s Sentinel System Solution is impacting MDMs.

Automation is proving to be a key driver for the future of testing. Visit us at Booth #135 for more information!

The Northeast Product Safety Society (NPSS) is holding its annual Vendor's Night on November 14, 2007. QuadTech representatives will be on hand at the event. For more information please visit www.nepss.org for more information.

Exciting things are happening at QuadTech. Here's a look at what to keep an eye out for!

With a greater focus on the customer, QuadTech is getting ready to launch newly redesigned website, with expanded search capabilities and improved usability. The new www.quadtech.com will be “a comprehensive, user-friendly website with dedicated resources for the medical community, as well as expanded content for all our customers,” says QuadTech President and CEO, Phil Harris.

With a continued focus on customer service and support, Harris says, “Most notably, we’re adding a client portal for our customers to use as a resource.” The portal includes a forum and discussion board, and is just one way QuadTech is demonstrating their commitment to excellence in customer service.

Shari Richardson, EST Product Manager at QuadTech has been invited to write an article for the November 2007 issue of Conformity Magazine. How to Choose a Hipot Tester will discuss the uses and features, and what's important to know when selecting a Hipot tester. The features within a new Hipot tester have been added due to demand from the industry and most importantly safety.

Additional information and other QuadTech articles can be found at www.quadtech.com.

QuadTech will be releasing the latest version of its automation software, CaptivATE 3.2. CaptivATE 3.2 has been developed in strict accordance with QuadTech's Software Development Lifecycle process to build-in quality. A key feature in the updated software is the ability to output data to a csv file for easy import of data from CaptivATE into an MES system.

Please contact us for more information on the upcoming release of CaptivATE 3.2.

Patient Source Current, in IEC60601-1 terminology, is Patient Leakage Current. This is the leakage current flowing out of an applied part, through the patient, and returning back into ground.

Patient Sink Current, in IEC60601-1 terminology, is F-Type Leakage Current. This is the leakage current flowing from the patient, back into a BF or CF applied part as a result of 110% of highest rated mains voltage being applied to the applied part.

Top

Our product requires boot up time for the operating system to be ready prior to making leakage current measurements. The product must also be shut down properly before removing power from the DUT. How can this be implemented in your CaptivATE software?

QuadTech’s CaptivATE will apply power to the DUT and can prompt the operator to boot up the operating system. The operator can then tell the software to begin making measurements. QuadTech’s test system will automatically scan through multiple leakage current test points without removing power from the DUT. After the measurements are complete, the software will prompt the operator to shut down the DUT. After the DUT is shut down, the software will then remove power from the DUT.

This will ensure two things:

The operating system can be fully started and functions on the DUT can be engaged to create a “worst case” leakage current condition prior to making measurements.
The operating system can be safety shut down to avoid operating system errors that are caused by improperly shutting down the operating system.

If you have any additional questions please email our application engineers.