As the trend toward bringing medical care home intensifies, incorporating the right power supply into a home healthcare device is key.
The ME60 Series, recently introduced by SL Power Electronics Corp., meets the latest electromedical safety standards for home healthcare devices.
The push to bring medical devices and therapies into the home will likely only get stronger as design experts, medtech inventors, and even FDA highlight the demand for home care. With this comes a host of issues—the device must be intuitive to use, incorporate patient training, and encourage loyalty.
One issue that may not come to mind immediately, but probably should? The issue of the power supply for that home healthcare device.
Power supplies used for medical devices are held to electromedical safety requirements. FDA has announced that the latest issued standard, ANSI/AAMI/IEC 60601-1-2 Edition 4, will be mandatory by April 2017. Among the changes in the latest edition is specification of immunity test levels for three specific locations: the professional healthcare facility, the home healthcare setting, and special environments.
Power supplier SL Power Electronics Corp., based in Ventura, CA, recently released its ME60 series, developed to meet the home healthcare power supply requirements set forth in the ANSI/AAMI/IEC 60601-1-2 Ed. 4.
Speaking with MD+DI at November's MD&M Minneapolis conference, Cochise Mapa, director of Global Product Management at SL Power, pointed to the importance of an EMC standard for the home setting. Homes, he says, "are susceptible to a noisy environment and disturbances." Carpets, for instance, generate electrostatic discharge, so it's important to design power supplies that can continue normal operations with such factors. Not only is the home setting less regulated than a hospital, Mapa says, but "in those environments you don't have the stable, clean power you with a hospital."
Mapa says the ME60 series is intended for use with home healthcare devices, including those used for patient monitoring, therapeutic, and surgical applications.
In addition to meeting the 4th edition standard, SL Power's ME60 medical-grade external power supplies also meet the new U.S. Department of Energy's Level VI efficiency requirements and the more stringent Class B electromagnetic interference (EMI) standard, according to a company press release.
While the standard isn't yet mandatory, Mapa says SL Power is already working with medical device manufacturers to add these power supplies to their systems. Given the unpredictable timing of device approvals or clearances, it makes sense for a manufacturer designing a new product to integrate a compliant power supply early, he points out.
|Check out the future of medical technology at the world's largest medical design and manufacturing event—register for the MD&M West Conference, February 9-11, 2016.|
[Image courtesy of SL POWER ELECTRONICS CORP.]