true wearables
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© 2016-2020 True Wearables, Inc.
UMD-0001 REV D
82
DEVICE PERFORMANCE, CONT.
Comparison to Reference Pulse Rate
Oxxiom
Pulse
Oximetry
System
Human
Subjects
(55-103
bpm)
Electronic
Pulse Simulator
(25-250 bpm)
3 bpm Arms
specification
for range of
25-250 bpm
# points (
n
) 47996
1092
Pass
A
rms
(bpm)
2.8
1.6
Notes:
• In the study with human subjects, Oxxiom was compared with
4 different reference pulse oximetry systems (largest Arms
reported). Tested on a Population of 10 adult subjects, and 40
Oxxiom devices (4 Oxxiom devices per subject). Subjects with
normal perfusion levels, and SpO2 levels between 70% and
100%.
• In the data collection with electronic pulse simulator, PA was
varied between 0.025% and 6%, and SpO2 levels between
70% and 100%. 4 Oxxiom devices were tested.
The following table summarizes the PR accuracy results
for the overall range (25 bpm to 250 bpm) obtained with
human subjects and electronic pulse simulator:
