SpO
2
Specifications
16-12 EarlyVue VS30 Instructions for Use
SpO
2
Accuracy Specifications
The SpO
2
accuracy was validated in human studies against arterial blood sample
reference measured with a CO-oximeter. In a controlled desaturation study, healthy
adult volunteers with saturation levels between 70% and 100% SaO
2
were studied as
recommended in ISO 80601-2-61.
Note
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor.
However, it can be used to demonstrate that a particular pulse oximeter monitor
reproduces a calibration curve that has been independently demonstrated to fulfill a
particular accuracy specification.
The results of the study are shown below. Representative sensors were tested to cover
all of the compatible SpO
2
sensors. All representative sensors were tested with 12 healthy
adult subjects with the following characteristics:
• Six male subjects and six female subjects
• Age range of the subjects: 19 to 39 years
• Skin tone: from light to dark brown
For each sensor, more than 300 blood samples were available for comparison, equally
spread over the range from 70% to 100% SaO
2
.
The A
rms
(SpO
2
Accuracy [root mean square]) values shown below, especially in the sub-
ranges from 70-80%, 80-90% and 90-100% SaO
2
, represent the results of this study.
Because pulse oximeter measurements are statistically distributed, only about two-thirds
of the measurements can be expected to fall within the specified accuracy compared to
CO-oximeter measurements.
Wavelength Range
3
500 nm to 1000 nm for all specified sensors
Maximum Optical Output Power 15mW for all specified sensors
1. Sensor accuracy was obtained by performing controlled hypoxia studies on healthy, non-smoking adult vol-
unteers The SpO
2
readings have been compared to CO-oximeter measurements on arterial blood samples. To
represent the general population, data from at least 10 subjects (male and female) with a wide range of skin
color was taken to validate SpO
2
accuracy.
2. The specified Pulse Rate accuracy is the root-mean-square (RMS) difference between the measured values
and the reference values. Pulse rate accuracy has been validated with an electronic pulse simulator.
3. Information about wavelength ranges can be useful for clinicians performing photo-dynamic therapy.
Parameter Specification
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