15
2023
-
05
Patient monitor approved for market
Recently, the State Drug Administration reviewed and approved the registration application of the "patient monitor" innovative product produced by Shenzhen Koman Medical Equipment Co., LTD.
The product consists of a host, plug-in modules and accessories. Ecg (including ST segment measurement and arrhythmia analysis), impedance respiration, body temperature, pulse oxygen saturation, pulse rate, noninvasive blood pressure, invasive blood pressure, respiratory and end-respiratory carbon dioxide, anesthetic gas, noninvasive cardiac output (for adult patients only), invasive cardiac output (for adult patients only) can be monitored. At the same time, it has the functions of electrocardiogram, PICC, respiratory oxygenogram, renal function calculation, hemodynamic calculation, oxygenation calculation, ventilation calculation, drug calculation and recorder. The product is intended to be used by trained and qualified professional clinicians and nurses in healthcare Settings, including operating rooms, icus and general departments.
The product adopts the ECG signal adaptive filtering technology and the four-electrode ECG system technology, which can realize the real-time positioning of the catheter end by observing the change of the ECG P wave in the cavity in real time and feedback the catheter end position. Compared with the traditional central vein catheterization method, the product has the function of central vein catheterization end positioning, which helps to improve the PICC catheter placement rate.
The drug regulatory authorities will strengthen post-market supervision of the product to protect the safety of patients.
Source: State Drug Administration
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