Originally Published EMDM May/June 2005
Industry News
Industrial Leak Detection Method Used for Blood Pumps
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| The H2000 uses a hydrogen-based method to detect leaks in medical devices. |
A leak detection method typically used in manufacturing lines has been employed for a medical device for the first time. Berlin Heart AG (Berlin), a specialist in cardiac support implants, now uses a detection device based on the hydrogen method to test blood pumps for leaks.
Developed by Sensistor Technologies AB (Linköping, Sweden), hydrogen testing technology exploits the gas’s rapid diffusion properties to identify small openings and punctures. Hydrogen is the lightest element and has the lowest viscosity of any gas. Because of its high molecular velocity, it spreads more rapidly in a given volume, passing through leaks more easily than other gases. In addition, hydrogen atoms are less likely to stick to surfaces than helium atoms.
Sensistor’s hydrogen-based leak detection device can detect leaks as small as 5 ¥ 10–7 mbar /L/sec. Offered as an alternative to helium-based tests, the H2000 can be operated with a standard mixture of 5% hydrogen and 95% nitrogen. Operators can easily flush out the gas after tests are completed, according to Sensistor. The detection method is nontoxic, nonflammable, and noncorrosive.
Dietmar Ries, quality management and regulatory affairs manager at Berlin Heart AG, says that the H2000’s accuracy and ease-of-use were core factors in the selection of the device. “Concerning our heart implants, we needed a precise leak detection device that is 100% reliable. [We needed] accuracy of measurements, which is guaranteed by the hydrogen method,” he comments. “For us, another clear advantage lies in the comfortable handling. With the H2000, we are no longer dependent on a stationary measuring apparatus. Therefore, we are spatially and temporally much more flexible.”
For more information, contact Sensistor Technologies AB, Box 76, SE-58102 Linköping, Sweden; phone: +46 1335 5900; fax: +46 1335 5901; e-mail: mail@sensistor.se; Internet: www.sensistor.se.
Copyright ©2005 European Medical Device Manufacturer
