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510(k) Data Aggregation
K Number
K023723Device Name
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
Manufacturer
FMS, FINAPRES MEDICAL SYSTEMS BV
Date Cleared
2003-10-23
(352 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
FMS, FINAPRES MEDICAL SYSTEMS BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K023338Device Name
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2
Manufacturer
FMS, FINAPRES MEDICAL SYSTEMS BV
Date Cleared
2003-05-09
(214 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
FMS, FINAPRES MEDICAL SYSTEMS BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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