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Medical Device Regulation

(EU) 2017 / 745 certified

HCTronic Heater-Cooler System

“A new generation of Safe, Reliable and Clean Heater-Cooler systems designed to impress.”

 

The HCTronic Heater-Cooler system concerns a new generation HCU for use during cardiac procedures in conjunction with a Heart-Lung Machine (HLM). 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. Our company has obtained certification in accordance to EN-ISO 13485:2016 & Medical Device Regulation (EU) 2017 / 745. 

Most important features:

- Fully Redundant system.
- Automated cleaning cycle.
- No additional single-use components needed.

Disclaimer: This product is only approved for clinical use in the European Union.