Microlife OXY 200 Mode D'emploi page 9

Technical alterations reserved.
Note 1: The fingertip pulse oximeter measurements are
statistically distributed, only about two-thirds of pulse oxim-
eter equipment measurements can be expected to fall
within ±2% A (Average-root-mean-square-error) of the
rmse
value measured by a co-oximeter.
Note 2: The statistic conclusion of a controlled desatura-
tion study which is guided by «ISO 80601-2-61, Annex EE,
guideline for evaluating and documenting SpO accuracy
2
in human subjects». The statistic result displayed the accu-
racy distribution between the range of 70% – 100%, which
is 2.83%.
Any serious incident that has occurred in relation to the
device shall be reported to the manufacturer and the
competent authority of the Member State in which the user
and / or the patient is established.
The device is a Class IIa medical device. Device complies
with European Regulation on medical devices EU MDR
2017/745.
Microlife OXY 200 7 EN