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The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters. The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator. The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products. The TFC can provide all signals as well as measured and derived parameters to the analog output interface and can acquire signals from the analog input interface.

The medical device Task Force® CORE (TFC) with software version 1.0.7 is a new product, which is intended to be used in professional healthcare facilities and operated only by qualified healthcare professional staff, as described in the Indications for use. The Task Force® CORE is intended to be used for the non-invasive continuous measurement of blood pressure and pulse rate, and the determination of associated derived hemodynamic parameters. . The principle of a continuous non-invasive measurement of a blood pressure is based on the Pénaz-Principle (vascular unloading). The TFC consists of several components necessary for the intended operation: - . Task Force® CORE Main Unit -TFC MU (see Figure 1) connected to an application computer via USB. - . Applied parts (detachable components): CNAP® Classic Sensor Unit (see Figure 2) and TFC NBP Cuffs (see Figure 3) - The TFC I/O Cable for using the Analog I/O interface (see Figure 4) - Task Force® CORE Viewer as graphical user interface (see Figure 5) and TFC Driver, executed ● on an application computer (third - party manufacturer). Please note that the application computer is not a part of the subject device (SD) and therefore not within the scope of this submission.

The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters. Alarms are generated for blood pressure parameters and pulse rate. The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals.

The CNAP® Monitor 500 HD is a stand-alone device for continuous non-invasive blood pressure and hemodynamic monitoring with alarming functionality. The continuous non-invasive blood pressure is measured on the patient's finger using a double finger cuff, the oscillometric blood pressure measurement function (Advantage 2.0 OEM module by SunTech Inc.) is used for intermittent calibration of the continuous blood pressure curve. Medium priority alarming can be set for blood pressure beat values and pulse rate.

The Task Force® Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's hemodynamic parameters using Impedance Cardiography (ICG), Electrocardiography (ECG), and photoplethysmography (continuous), oscillometric Blood Pressure (oscBP) and continuous blood pressure. The TFM continuously monitors the subject's hemodynamic parameters without reporting any diagnosis. Every measurement must be supervised by a medical trained professional. The Task Force® Monitor 3040 is a diagnoses aiding device and therefore not designed for vital sign monitoring or self-monitoring of patients.

The device architecture of the TFM is equivalent to the BioZ.pc. The TFM system consists of a Patient Biosignal Electronic System (PBES) and a PC for calculating and displaying the hemodynamic parameters. ICG signals from a patient are assessed using the same method as the predicate device (8 electrodes, injecting a minimal current). The user inputs the patient's data into the TFM software on the PC including gender, age, height, weight, hematocrit and the distance between the inner ICG electrodes. The PC runs Windows 2000 operating system. The parameters are displayed on a full color screen and measurement data can be stored on the PC's hard disk. The TFM calculates and displays the same hemodynamic parameters as the predicate device.