Bioz Dx Hemodynamic Monitor with Philips 12-lead Ecg Model 5100

FDA-Cleared Indications

• Noninvasive measurement and monitoring of cardiac hemodynamic parameters using impedance cardiography.
• Use with ECG signals to support assessment of cardiovascular function in patients requiring hemodynamic monitoring.

Clinical Applications

• Noninvasive assessment of cardiac hemodynamics in a clinical setting.
• Monitoring cardiac function in patients with suspected or known cardiovascular disease.
• Use alongside a 12-lead ECG when evaluating hemodynamic status.

Reported off-label uses

• Research and clinical assessment of hemodynamic trends in heart failure and atrial fibrillation.
• Adjunctive monitoring during outpatient or ambulatory cardiovascular evaluation.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The monitor is noninvasive and uses surface electrodes; correct skin preparation and electrode placement are important for reliable measurements.
• It is intended to work with the specified Philips 12-lead ECG configuration and should be used according to the manufacturer’s compatibility instructions.
• This device does not replace echocardiography, invasive pressure monitoring, or other diagnostic testing when those studies are clinically indicated.
• MRI compatibility should not be assumed; verify the device, cables, and accessories with the manufacturer before entering an MRI environment.
• Interpret results in the clinical context because motion, poor electrode contact, arrhythmias, and other factors can affect impedance-based measurements.