Zoll Medical, a manufacturer of resuscitation devices and related software solutions, has received clearance from the State FDA of China to market and sell its R Series Code-Ready defibrillators to hospitals in the People's Republic of China. The SFDA is equivalent to the U.S. Food and Drug Administration, Zoll said.
The original R Series ALS, along with the new R Series BLS and R Series Plus models, are designed to extend smart and ready defibrillation to hospital departments for resuscitation. The R Series BLS is an automated external defibrillator (AED) that becomes a life support device for critical care.
The R Series Plus, which has both AED and ALS capabilities, also has networking capabilities and See-Thru CPR, which allows the professional rescuer to view a patient's underlying cardiac rhythm during resuscitation efforts without the need to stop compressions. The models provide the Real CPR Help feature that provides real-time feedback on the rate and depth of chest compressions, the company said.
The cables, paddles, batteries, handles and electrodes are also common to ensure that clinicians will not encounter a mismatch during a code, according to the Chelmsford, Mass.-based company. In addition, the R Series can use wireless networking to ensure code-readiness. Based on standard WiFi technology, the R Series sends a status of its state of readiness at a programmed time.
"Since defibrillators are widely distributed throughout hospitals, and their use is both infrequent and extremely critical, code readiness helps clinicians save more lives," said Jonathan A. Rennert, president of ZOLL. "We're extremely pleased that the SFDA of China recognizes the value the R Series platform has in helping to ensure readiness any time a code occurs."