The HCTronic Heater-Cooler system concerns a new generation HCU for use during cardiac procedures in conjunction with a Heart-Lung Machine (HLM). Medical Device CE Certification process according to Medical Device Regulation (EU) 2017 / 745 is currently ongoing for this new device. Our system uses proprietary heat pump technology (patent pending) to control the temperature without the need for buffer tanks and has a fully automated cleaning cycle to avoid manual chemical cleaning like conventional systems currently on the market. Evaluation of our fully automated disinfection process by an external test laboratory has confirmed its effectiveness. In addition to multiple safety measures to prevent contamination of our device, extensive testing has shown that our process effectively reduces bacterial load of both fast-growing waterborne bacteria and Mycobacterium chimaera bacteria. More information to follow soon. Please follow us or reach out if you are interested!
Company’s Keywords:
medical devices, cardiopulmonary, perfusion, cardiacsurgery
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