Section 5- Measurement Validation; Subject Demographics; Arms Results - MedLinket AM801 Manual Del Usuario

Section 5- Measurement Validation

The Pulse oximeter accuracy has been validated in human studies against arterial
blood sample reference measured with a CO-Oximeter. In a controlled desaturation
study, healthy adult volunteers with saturation levels between 70% and 100% SaO2
were studied.

Subject Demographics

The population characteristics for those studies as follow table 5
Table 5—PULSE OXIMETER Clinical study Subject Demographics Record.
Subject
Gender Age
#
1# M
2# M
3# F
4# M
5# F
6# F
7# F
8# M
9# F
10# M
11# F
12# M

ARMS Results

The final analysis was performed on 241 data points collected across 12 subjects.
The SpO2 accuracy performance of each pulse oximeter and sensor combination is
identified below
Where:
ARMS is the accuracy root mean square.
SpO2 is the test pulse oximeter readings during sample i.
Sao2 is the Average Reference CO-Oximeter functional oxygen saturation reading
during sample i.
n is the number of points.
Height Weight
(cm) (kg)
31
160 70
24 165 55
22 160 45
29 175 60
22 160 49
19 160 45
21
162 54
34 192 102
27 178 58
23 178 78
24 174 80
26 169 65
English 21
Skin Tone
Light
Light
Light
Medium Dark
Light
Light
Light（White）
Light（White）
Light（White）
Dark dark
Dark dark
Dark dark
Remark
Asian (Chinese)
Asian (Chinese)
Asian (Chinese)
Asian (Chinese)
Asian (Chinese)
Asian (Chinese)
Caucasian
Caucasian
Caucasian
African
African
African