Search Results

The LiDCOp/us Hemodynamic Monitor is intended for use as a diagnostic aid for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in patients greater than 88lb (40kg) in weight.

SUITABLE PATIENTS:
Patients requiring cardiovascular monitoring who have pre-inserted and venous catheters and preexisting peripheral arterial line access.

LOCATIONS OF USE:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories

The LiDCOplus Hemodynamic Monitor calculates a number of derived parameters: Body Surface Area, Systolic Pressure Vanation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the LiDCOplus Hemodynamic Monitor, outlining its regulatory classification and indications for use. It primarily focuses on the substantial equivalence of the device to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Ask a specific question about this device