User's Manual

9
measured values of oxygen saturation and the reference value. The formula is as
follows:
A
rms
: accuracy.
n: test sample quantity.
SpO
2i
: measured value of pulse oxygen saturation during the first measurement
using the finger pulse Oximeter.
S
Ri
: reference value of pulse oxygen saturation during the ith measurement using the
carbon-monoxide-blood-gas analyzer.
4. Characteristics of Population under Clinical Research
The group of healthy adult volunteers for the study consisted of 12 subjects - 4
women and 8 men, The ages ranged from 18 to 50 years. The subject weights ranged
from 48 to 90kg. The subject Height ranged from 160 to 182cm. The Skin tones
included in the study were as follows: 3 subjects with dark pigmentation, 5 subject
with very light pigmentation. The remaining subjects with light (medium) skin tones
of Asian origins.
5. Graphical Plot of SaO
2
versus error (SpO
2
– SaO
2
)
6. The technology used in Finger Pulse Oximeter has been verified with accuracy
when there is no motion via human blood studies on healthy volunteers of both male
and female with light to dark pigmented skin in induced hypoxia studies in the range
of 70%-100% SpO
2
against a laboratory co-oximeter.
7. The technology used in Finger Pulse Oximeter has been verified with the pulse
rate accuracy of 25-250bpm range in the bench top test against Fluke Index 2
simulator and the Finger Pulse Oximeter.