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Patient monitor approved for marketing

CCFDIE| Updated: 2023-01-06

Recently, the innovative product "patient monitor" of Shenzhen Comen Medical Instruments Co., Ltd. is approved for marketing by China NMPA.

The product consists of the main unit, plug-in module and accessories. Indicators such as ECG (including ST segment measurement and arrhythmia analysis), impedance respiration, body temperature, pulse oxygen saturation, pulse rate, non-invasive blood pressure, invasive blood pressure, respiratory and end-tidal carbon dioxide, anesthetic gas, non-invasive cardiac output (only applicable to adult patients), invasive cardiac output (only applicable to adult patients) can be monitored, and functions such as ECG, PICC, respiratory oxygenation diagram, renal function calculation, hemodynamic calculation, oxygenation calculation, ventilation calculation, drug calculation and recorder are also available. The product is expected to be used by trained and qualified professional clinicians and nurses in medical institutions, and its application fields include operating rooms, ICUs and general departments. 

The product adopts ECG signal adaptive filtering technology and four-electrode ECG system technology, which can realize real-time positioning of catheter end during catheterization by observing the changes of P wave of intracavity ECG in real-time. Compared with the traditional central venous catheterization method, this product has the function of positioning the catheter end during central venous catheterization, which is helpful to improve the accuracy rate of PICC catheterization.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.