15.2 Calibration Not Required
As described in Section 15.1, the light absorption properties of
Hemoglobin vary with wavelength. The Pulse Oximeter technology used
in BabySat requires no ongoing calibration because the specified
wavelengths used in the LED light sources have been selected to be
within the calibration range required for the measurement.
15.3 Functional Oxygen Saturation
Pulse Oximeter is calibrated and clinically tested to measure functional
Oxygen Saturation of arterial Hemoglobin based on reference
measurements of fractional Oxygen Saturation with a laboratory co-
oximeter using arterial blood samples obtained from healthy adult
volunteer test subjects.
Functional Oxygen Saturation can be expressed as the following
formula:
(where % COHb represents % Carboxyhemoglobin and % MetHb represents
% Methemoglobin)
If the level of dysfunctional Hemoglobin is high (i.e., high level of
carboxyhemoglobin or methemoglobin), the accuracy of the functional
saturation measurement may be reduced.
15.4 Use of Functional Testers
Some third-party functional testers can be used by trained biomedical
sta to verify the functionality of Pulse Oximeters. These functional
testers typically operate by adjustments to the optical pathway and
allow the user to set various simulated values of saturation and Pulse
Rate. While such functional testers are useful for verifying function, they
are not able to assess clinical accuracy. An evaluation of the accuracy of
a SpO2 measurement generally requires a clinical study. See the section
below for more information on clinical accuracy.
CAUTION.
A functional tester cannot be used to assess the accuracy of a
Pulse Oximeter probe or a Pulse Oximeter monitor. If you
have any concerns regarding functionality, contact Owlet.
15.5 Clinical S
p
O2 Accuracy Study Re
p
ort
Su
mm
ary
S
p
O2 Accuracy
Analysis Range
Non
-m
otion
Study Results
M
otion Stud
Results
70%
to 1
00% ±
2.
7
2
%
Ar
m
s
±
2.
6
3
%
Ar
m
s
70%
to
80% ±
3.
0
5
%
Ar
m
s
±
3.11
%
Ar
m
s
80%
to
90% ±
2.
67
%
Ar
m
s
±
2.22
%
Ar
m
s
90%
to 1
00% ±
2.4
6
%
Ar
m
s
±
2.
6
3
%
Ar
m
s
5
0
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