16.6 SpO2 and Pulse Rate Performance
Parameter
Specification
SpO2 range
1% to 100%
Pulse Rate range
30 to 300 beats per minute (bpm)
SpO2 Accuracy (70% to 100%)
No Motion: ± 3.0% Arm
Motion: ± 3.0% Arms
Pulse Rate Accuracy*
No motion: ± 3 bpm Arm
Motion: ± 5 bpm Arms
! NOTE.
Established by a study comparing Pulse Rate measured using
BabySat to a calibrated Fluke Biomedical ProSim™ 8 Vital Signs
Simulator with SPOT Light SpO2 Simulator. Brand and trade names
remain the property of their respective owners. Usage does not
imply an endorsement.
! NOTE.
Because Pulse Oximeter equipment measurements are statistically
distributed, only about two-thirds of Pulse Oximeter equipment
measurements can be expected to fall within ± Arms of the value
measured by a co-oximeter.
Factors that may aect Sensor performance
I
mproper Sock placement and
/
or fit may a
ect Sensor performance.
Refer
to Section 8.
1
for Sock fit and placement information
Performance and accuracy may be a
ected by poor circulation, variations in
skin pigmentation and
/
or skin thickness as well as skin temperature
Excessive motion will cause the Sensor to pause transmitting readings
Powders, creams, or lotions applied to the baby
’
s foot under the Sock may
cause skin irritation and trouble getting data
Electrical equipment that emits radio frequencies may interfere with
performance of
[
BabySat
/
the Sensor
]
. Refer to Section
17
for further details
D
irect sunlight on the baby
’
s foot may a
ect performance of the Sensor.
Owlet recommends that Sensor be shaded from direct sunlight
Excessively bright direct lighting on the Sensor may cause trouble acquiring
data.
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