Riester ri-vital Instrucciones De Uso página 73

2)
The device was clinically validated with the sensors listed on the next page by studies
of induced hypoxia between 70% - 100% SpO2 and by comparing the measured values
with the results of a CO-oximeter invitro measurement. The subjects were healthy, adult
volunteers with light and dark skin pigmentation of both sexes. The accuracy of the
individual sensors can be found in the documentation of the respective sensors.
3)
The device was validated in the laboratory with simulators Biotek Index 2, Fluke Prosim
8 and an internal simulator of the Rudolf Riester GmbH in the range between 70% -100%.
The perfusion index (percentage modulation of the IR signal) was between 0.025% and
0.15%.
4)
The device was validated in the laboratory the simulators Biotek Index 2 and an internal
simulator of Rudolf Riester GmbH. The Biotek Index 2 simulator has built-in artefact
signals. Its own simulator allows scaled pulse waves with artefacts to be scaled to
different saturations and to be fed into a Rudolf Riester pulse oximeter. SpO2 and pulse
values were tested.
5)
Pulse oximetry is used to measure the pulse frequency as the reciprocal of the duration
between the extremes of the absorption curves. The pulse display of the device in
conjuntion with the sensors was performed in the laboratory using the simulators Biotek
Index 2 and Fluke Prosim 8 in the pulse range between 30 and 250 min-1. Measurements
of pulse rate in pulse oximeters FSpO2 are statistically distributed compared to the true
heart rate FR. Therefore approximately 68% of the pulse measurements are within the
indicated error limits ePRMSÐ
6)
The term „reduced perfusion" is not clearly defined by measurement technology and
normative. The term „reduced perfusion" is used here if the pulsatile portion of the signal
is less than 0.25%. This definition is also used by other manufacturers of pulse oximeters.
If the perfusion index indicates a pulsatile fraction of less than 0.25% (only one bar filled,
orange display), it is recommended to position the sensor onto a better perfused place.
SpO2:
Pulse:
ri-vital
TECHNICAL DATA
70% - 100%: ARMS = ± 1.79%
30 - 250 BPM ± 3 BPM
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