Chapter 11: Specifications
11-2
Clinician’s Operation Manual
SpO
2
for the WW1020 Oximeter
SpO
2
Range:
0-100% Functional Saturation (Display Maximum: 99%)
SpO
2
Resolution: 1 count (%SpO
2
)
SpO
2
Averaging:
8 beats
Calibration:
Factory calibrated over range 70% to 100% SpO
2
using human blood
samples to functional saturation. Test methods are available upon request.
No in-service calibration is required.
Sensors:
Red: 660 nm, 2 mW (typical)
Infrared: 905 nm, 2-2.4 mW (typical)
SpO
2
Accuracy:
70 to 100% SpO
2
, less than 70% SpO
2
is undefined.
Sensor
SpO
2
Accuracy in
Normal Conditions
1, 2
SpO
2
Accuracy in
Low Perfusion Conditions
1, 3
SpO
2
Accuracy in
Motion Conditions
15
BCI® 1300
±2 A
RMS
±2
9
A
RMS
±3 A
RMS
BCI® 1301
±2
4
A
RMS
±2
9
A
RMS
±3
13
A
RMS
BCI® 1302
±3
14
A
RMS
±3
14
A
RMS
unspecified
BCI® 1303
±2
5
A
RMS
±2
9
A
RMS
unspecified
BCI® 3025
±2.5
6
A
RMS
±2.5
10
A
RMS
unspecified
BCI® 3026
±3.5
14
A
RMS
±3.5
14
A
RMS
unspecified
BCI® 3043
±3 A
RMS
±3 A
RMS
unspecified
BCI® 3044
±2 A
RMS
±2 A
RMS
unspecified
BCI® 3044S
±2
7
A
RMS
±2
11
A
RMS
unspecified
BCI® 3078
±3.6 A
RMS
±3.6 A
RMS
unspecified
BCI® 3178
±2 A
RMS
±2 A
RMS
unspecified
BCI® 3178S
±2
8
A
RMS
±2
12
A
RMS
unspecified
BCI® 3444
±2 A
RMS
±2 A
RMS
unspecified
Nellcorr® DS100A
±2.5 A
RMS
±2.5 A
RMS
unspecified
1
Because pulse oximeter measurements are statistically distributed, only about two-thirds of pulse
oximeter equipment measurements can be expected to fall within the ± A
RMS
of the value measured by
the CO-oximeter.
2
The WW1020 has been validated on 10 adult volunteers that did not have health problems and were
non-smokers. The study was conducted at oxygen concentrations evenly distributed over an SpO
2
range
of 70-100%.
3
Pulse Amplitude 1% to 0.1%. Tested using industry standard simulator.
4
Clinical accuracy based on BCI® 1300;
5
Clinical accuracy based on BCI® 1302.
6
Clinical accuracy based on BCI® 3026;
7
Clinical accuracy based on BCI® 3044.
8
Clinical accuracy based on BCI® 3178;
9
Clinical accuracy based on BCI® 1302.
10
Clinical accuracy based on BCI® 3026;
11
Clinical accuracy based on BCI® 3044.
12
Clinical accuracy based on BCI® 3178;
13
Clinical accuracy based on BCI® 1300.
14
For neonatal patients, 1%-SpO
2
was added to account for theoretical differences in pulse oximetry
function between adult and neonatal hemoglobin. This investigation was performed on adults only.
15
Motion patterns used consisted of tapping and rubbing. Subjects varied the motion frequencies to a
maximum of 300 cycles per minute. A maximum amplitude of approximately 2.5 cm was used in this
study.
Summary of Contents for 10
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