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The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in hospitals, clinics and research institutions.

The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device. The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector. The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development. The embedded software in the device provides computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance. The addition to the Finapres NOVA software covered in this application is mostly related to the addition of a software module called ANS (Autonomous Nervous System). (Para)sympathetic function can be assessed by a physician through arterial Baro Reflex Sensitivity (BRS) testing and Heart Rate Variability (HRV) analysis. The ANS software module calculates additional parameters, derived from pressure and ECG signals measured with the Finapres NOVA, which are related to Baro Reflex Sensitivity and to Heart Rate Variability. A baroreceptor is a sensory nerve ending in de wall of the aortic arch and carotid bulbus that is sensitive to changes in blood pressure. These baroreceptors act as receptors of central reflex mechanisms that regulate the blood pressure. The blood pressure is regulated by altering heart rate (baroreflex), cardiac contractility, vasoactivity and humoral activity. The main function of the baroreflex is to maintain a stable blood pressure. To quantify whether the baroreflex is functioning properly the linear regression line of the relation between systolic blood pressure and resulting interbeat interval is estimated. The slope of this linear regression line is defined as the Baro Reflex Sensitivity (BRS) and is to be used in the assessment of the (dys)function of the baroreflex. Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is determined using the beat-to-beat interval. Using this additional software module, the Finapres NOVA only presents parameters derived from the interbeat interval (HRV) and blood pressure (BRS) to the user. It is up to the user to draw conclusions on whether these values are normal or abnormal. The additional Remote Control Module provides the possibility to monitor and control a Finapres Nova from a PC. This can be achieved by establishing a network connection from a PC to the Finapres Nova. Two types of connections can be made: one that is restricted to viewing and one that allows full control of the Finapres Nova. The additional Nova Scope PC application is used to view and review measurement files recorded with the Finapres Nova on a PC instead of on the NOVA instrument itself.

The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapes NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in a professional medical environment.

The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device. The embedded software in the device provides computation of real-time and beat-tobeat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance. The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector. The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development.

The Finometer is intended to be used when there is a need for a noninvasive hemodynamic monitor. The Finometer provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow as well as in various hemodynamic parameters derived from these pressure and flow signals. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers. The noninvasively blood pressure waveform is measured by using the Finapres method of Peñáz/Wesseling. Hemodynamic parameters include cardiac output and total peripheral resistance based on the Modelflow method of Wesseling. The Finometer is intended to be installed and operated by a qualified physician or operator. Pressure measurements are validated for subjects above 18 years of age. The only mode of measuring blood pressure accurately is when the device is used with the return-to-flow method of calibration, if the pressure data are to comply with the recommendations of the AAMI SP10 standard. Modelflow built-in calibration is useful from 18 years on. Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution. The physiological parameters provided by the device have clinical significance only if determined by a physician and should not be used as the sole means for a patient's diagnosis. The data provided by the device can be further processed by the included PC-based BeatScope software.

The Finometer Noninvasive Hemodynamic Monitor is a stationary device to record continuous noninvasive arterial blood pressure as well as additional hemodynamic parameters. The Finometer is a stationary device. It consists of the Main Control Unit with electronics and a solidstate disk for storage. The Main Control Unit also contains the two pressurized air circuits, including air pumps, for the measurements using the Finapres methodology and for the RTF calibration methodology. A Frontend Unit is used to provide an interface for the electronic signals from the Main Control Unit electronics and air supply to the forger cuffs, an arm cuff, and an analog input/output unit. The Frontend Unit connects the Main Control Unit to the forger cuff, which in turn consists of an inflatable air bladder and an infrared photoplethysmograph The Main Control Unit microprocessor has an internal solid-state disk storing up to 24 hours of continuous blood pressure and derived hemodynamic data. The Main Control Unit is equipped with an RS232 serial interface to transfer the data stored in the Finometer disk to a PC and to allow remote control of the Finometer. The analog input/output unit provides four analog signal outputs for connection to other data acquisition systems, and provides three analog signal inputs for sampling and storing of external signals simultaneously with the Finometer data. An external (intra-arterial) blood pressure signal can be used to replace the finger blood pressure. The Finometer then will use the external pressure signal to derive all parameters. BeatScope PC-software is also delivered with the Finometer to enable downloading, viewing, and further handling of Finometer data. BeatScope provides the capability of on-line monitoring, storage, and limited control of a Finometer measurement on a remote PC.

The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements. The PC-based BeatScope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.

Portapres is a portable, battery-powered device to record continuous non-invasive arterial blood pressure. Portapres is intended for 24-hour continuous recordings in ambulatory subjects. The device includes a Neoprene belt to be worn around the waist, with compartments for the Main Unit with electronics and memory card, a Pump Unit with an air pump, and a NiCd or Li battery pack. Connected to the waist belt Main Unit and Pump Unit is a Wrist Unit, used to interface with the signals from the electronics and air supply in the waist belt to the finger cuffs. The Wrist Unit then connects to a finger cuff, which consists of an inflatable air bladder and an infrared photoplethysmograph. The plethysmograph measures the finger arterial volume which varies with the patient's blood pressure. The Wrist Unit controls the pressure in the cuff bladder so as to keep the arterial volume constant at a level (the setpoint) determined during startup. The Wrist Unit contains a pressure transducer that measures the cuff pressure as an indirect measure of the patient's blood pressure. Also connected to the Wrist Unit is a hydrostatic height correction unit that compensates for the hydrostatic component of the blood pressure in the finger when this is not at heart level. This allows the patient free hand movement in ambulatory applications. Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The microprocessor has an internal flash memory card for storage of blood pressure wave form data. The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.