Smart One Oxi
English
Rev.1.8
User Manual
Page 28 of 35
Time zero = t
PEF
- (V
PEF
/PEF)
Where
PEF is the peak expiratory flow;
t
PEF
is the elapsed time at PEF;
V
PEF
is the expired volume at PEF
For the oximetry measurements, the device conforms to the requisites of the following
standard:
ISO 80601-2-61:2017 Medical electrical equipment
–
particular requirements for basic safety
and essential performance of pulse oximeter equipment
Range (SpO2)
Arms (%)
70-100 %
±
1.90
70-80 %
± 2.32
80-90 %
± 1.71
90-100 %
± 1.43
The Arms (Accuracy Root Mean Square), as mentioned in the above-cited standard,
represents the accuracy of the device in terms of mean quadratic error of each SpO2
measurement, obtained by pulse oximetry, in relation to the respective reference value of
SaO2, obtained by co-oximetry.
The listed ranges show the different saturation intervals of oxygen for which the accuracy
has been calculated.
The accuracy of the device cannot be assessed with a tester.
