According to the official website of the State Food and Drug Administration, the State Food and Drug Administration recently approved the application for registration of the innovative product "patient monitor" produced by Shenzhen Keman Medical Equipment Co., Ltd. It is reported that this 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.

It is reported that the product is composed of a host, a plug-in module, and accessories. 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-respiratory carbon dioxide, anesthetic gas, non-invasive cardiac output (only applicable to adult patients), invasive cardiac output (only applicable to adult patients) can be monitored for patients, and ECG, PICC, respiratory oxygenation diagram, renal function calculation, hemodynamic calculation Oxygenation calculation, ventilation calculation, drug calculation, recorder function.

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

The State Drug Administration said that the drug supervision and administration department will strengthen the post-marketing supervision of the product to protect the safety of patients' use of equipment.