EasyManua.ls Logo

FINAPRES NOVA - 1.3 Intended User; 1.4 Intended Patient Population; 1.5 Device Classification

FINAPRES NOVA
98 pages
Print Icon
To Next Page IconTo Next Page
To Next Page IconTo Next Page
To Previous Page IconTo Previous Page
To Previous Page IconTo Previous Page
Loading...
1
Basic user manual
Finapres Nova
15
1 Introduction
1.1 Finapres Nova
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-to-
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 thermodilution.
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. The ECG module provides only a visual
clinical alarm.
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.
Except of the ECG module, no visual clinical alarms are given by the
Finapres Nova. The Finapres Nova can generate alerts for technical but
not for clinical issues.
Data produced by the Finapres Nova and/or the accompanying
software is intended as an adjunct in patient assessment. It should
not be used as a sole means for determining a patient's diagnosis.
1.2 Intended use and environment
The Finapres Nova is a standalone device intended for desktop use.
Measurements are to be performed under uninterrupted patient surveillance of
the operator.

Table of Contents

Related product manuals