(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.
16.4 Use of Functional Testers
A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.
16.5 Clinical SpO2 Accuracy Study Report Summary
Dream Sock 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: 19-28). The subject pool included
2 Black / African Americans, 8 Asians, 7 Caucasians and 1 subject of Hispanic / Latino ethnicity. 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. All
subjects completed the study without incident.
Arterial blood samples measured by co-oximeter (SaO2) are the reference method for simultaneously-obtained Dream Sock values
(SpO2). Skin pigmentation of the study subjects included at least three darkly pigmented subjects.
SpO2 accuracy results obtained from this clinical study are provided numerically in the following table and graphically on the next
diagram.
To Next Page
