Accuracy Of Spo2; Functional Oxygen Saturation; Why Inside The Ear - cosinuss c-med alpha User Manual

Accuracy of SpO
2
The SpO shall be measured with an accuracy of rms +/- 4% within the range of 70% –
2
100%.

Functional oxygen saturation

Functional oxygen saturation is the percentage of saturation given by the concentration of
oxyhemoglobin (cO2Hb) divided by the sum of the concentrations of oxyhemoglobin and
deoxyhemoglobin (cHHb).
According to the Clinical Laboratory Standards Institute (CLSI), the term for this ratio is
hemoglobin-oxygen saturation, and its designation is SO
For SpO this percentage saturation refers to arterial blood.
2
NOTE:
● The pulse oximeter equipment is calibrated to display functional
● The accuracy of the measurements are influenced by internal and
● SpO2 measurement accuracy of the c-med° alpha has been
● Based on statistical distribution, two-thirds of the measurements with
● The use of functional test equipment cannot be used to verify the

Why inside the ear?

The ear canal is an ideal place of measurement for vital sign monitoring:
● Blood supply: The ear canal is part of the body core and therefore optimally
supplied with blood. This is essential for all optical measurements on the body and
ensures the possibility for a data collection of high accuracy.
100 × ����2����
����2���� + ��������
oxygen saturation (SpO
external factors (See chapter: Warnings and precautions).
validated using a controlled desaturation study without movement in
healthy volunteers
(Men and women, adult age, non-smoking, normal weight,
skin tone according to Fitzpatrick scale)
and in reference to a secondary standard pulse oximeter. In this
desaturation study the c-med° alpha achieves an accuracy of
A = 1.85 %. Adding the accuracy of the reference pulse oximeter
RMS
(A = 2 %) this sums up to a final A
RMS
within the 4 % required in the standard DIN EN ISO
80601-2-61:2019.
the c-med° alpha can be expected to fall within the overall root mean
square of A =3.85% given above.
RMS
measurement accuracy.
.
2
).
2
within a range of 70%-100% SpO
of 3.85 % which lies
RMS final
2
15