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Recently, the State Medical Products Administration approved the registration application
for the innovative product "patient monitor" produced by Shenzhen Keman Medical Equipment Co.
, Ltd.
after review.
for the innovative product "patient monitor" produced by Shenzhen Keman Medical Equipment Co.
, Ltd.
after review.
The product consists of
a host, plug-in modules, and accessories.
It can monitor patients with ECG (including ST-segment measurement and arrhythmia analysis), impedance respiration, body temperature, pulse oximetry, pulse rate, non-invasive blood pressure, invasive blood pressure, respiratory and end-respiratory carbon dioxide, anesthetic gas, non-invasive cardiac output (only for adult patients), invasive cardiac output (only for adult patients), and has the functions
of electrocardiogram, PICC, respiratory oxygenation, 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 facilities in applications such as operating rooms, ICUs and general departments
.
a host, plug-in modules, and accessories.
It can monitor patients with ECG (including ST-segment measurement and arrhythmia analysis), impedance respiration, body temperature, pulse oximetry, pulse rate, non-invasive blood pressure, invasive blood pressure, respiratory and end-respiratory carbon dioxide, anesthetic gas, non-invasive cardiac output (only for adult patients), invasive cardiac output (only for adult patients), and has the functions
of electrocardiogram, PICC, respiratory oxygenation, 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 facilities in applications such as operating rooms, ICUs and general departments
.
The product adopts ECG signal adaptive filtering technology and four-electrode ECG system technology, which can realize the real-time positioning
of the catheter end during catheter insertion operation by observing the change of cavity electrocardiogram P wave in real time and feedback the position of the catheter end.
Compared with traditional central venous catheterization methods, this product has the function of central venous catheterization end positioning, which helps to improve the PICC catheter placement rate
.
of the catheter end during catheter insertion operation by observing the change of cavity electrocardiogram P wave in real time and feedback the position of the catheter end.
Compared with traditional central venous catheterization methods, this product has the function of central venous catheterization end positioning, which helps to improve the PICC catheter placement rate
.
The drug administration department will strengthen the post-marketing supervision of the product to protect the safety of
patients.
patients.
