Providing safety for implantable medical devices
23 Dec 2022
Radiation Therapy
For over 50 years, Biotronik has been developing medical devices to improve the quality of life of patient’s suffering from cardiovascular and endovascular diseases. One of the company's products is the Renamic Neo, a control unit that communicates with a medical device implanted in a patient, such as a pacemaker.
The control unit allows the physician or patient to read information such as battery status, heart rate, and other parameters necessary for the functioning of the implanted device.
By using Schurter components with low electromagnetic radiation, the Renamic Neo is the world's first device to read and program the implant completely wireless. Communication between the Renamic Neo and the implanted device is wireless via a low-power radio signal, and there must be no interference in the frequency range of this signal. When developing the application, EMC was therefore an important issue from the start.
Biotronik required that their products met the medical EMC standard EN 60601-1-2 and supplied Schurter with the equipment to test accordingly. There is now a shielded cabinet, where no radiation can penetrate from the outside. The product is placed in the cabinet, connected with cabling, and switched on. An antenna in the cabinet captures any signals around the frequency in question, and these go through a coax cable to a spectrum analyser outside the cabinet, which measures the signals. An algorithm determines an average value for these signals, which must lie between 3 and 20 dB."
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