BabySat has been clinically evaluated for SpO2 accuracy in 18 healthy
adult volunteers providing informed consent within an institutionally
approved clinical study protocol per the method of ISO 80601-2-61:2011
Part 201.12.1.101.2. The demographics of subjects included 9 males and
9 females (age: 22-37 yrs., weight: 106-194 lbs., height:59-73”, BMI:
19-29). There were 7 Caucasian subjects, 8 Asian subjects, 2 Black
subjects, and 1 Hispanic subject.Skin tones ranged from Type I to Type
VI on the Fitzpatrick scale. Motion was added by placing one of the
subject’s arms on a machine that simulates rubbing and touching
motions, at 2 to 4 Hz at an amplitude of 1 cm and a non-repetitive
motion between 1 to 5 Hz at an amplitude of 1 to 3 cm. There was no
significant dierence in accuracy as measured by Arms with the applied
motion simulation. All subjects completed the study without incidence.
Arterial blood samples measured by co-oximeter (SaO2) are the
reference method for simultaneously-obtained BabySat Pulse Oximeter
values (SpO2). Of the total number of study subjects, at least three or
15% subjects with darkly pigmented skin were included.
SpO2 accuracy results obtained from this clinical study are provided
numerically in the adjacent table and graphically on the following page.
Results of the clinical study demonstrate BabySat meets established
criteria for SpO2 accuracy (in non-motion conditions) for the range 70%
to 100% SaO2 per the referenced standards.
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