12-lead ECG monitoring, requiring 10 electrodes, is valuable for its ability to detect arrhythmias and acute myocardial ischemia, but placing 10 electrodes on a patient often requires too much work when compared with the benefit and extra maintenance required. It can even be impossible due to treatment the patient has already received or is due to receive.
12RL™ technology provides a 12-lead view, 12-lead ST monitoring and global QT/QTc interval measurement using a reduced leadset: only six electrodes in standard placement (RA, RL, LA, LL, V1 and V5) are required.
Studies have shown that observations were identical between 12RL and standard 12-lead ECGs for tachycardia, bundle branch and fascicular blocks, left atrial enlargement and the distinction of ventricular tachycardia from supraventricular tachycardia with aberrant conduction.
12RL enables 12-lead ECG monitoring on patients when a conventional 12-lead ECG is not practical. Since 12RL technology uses the standard electrode positions, switching from 12RL ECG to conventional 12-lead ECG just requires adding four electrodes.
The product is intended for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The product is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.