Spo For The Ww1020 Oximeter - BCI WW1020 Operation Manual

Chapter 11: Specifications
SpO for the WW1020 Oximeter
2
0-100% Functional Saturation (Display Maximum: 99%)
SpO Range:
2
SpO Resolution: 1 count (%SpO
2
8 beats
SpO Averaging:
2
Calibration:
Factory calibrated over range 70% to 100% SpO
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 Accuracy: 70 to 100% SpO
2
SpO
Sensor
Normal Conditions
BCI® 1300
BCI® 1301
BCI® 1302
BCI® 1303
BCI® 3025
BCI® 3026
BCI® 3043
BCI® 3044
BCI® 3044S
BCI® 3078
BCI® 3178
BCI® 3178S
BCI® 3444
Nellcorr® DS100A
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
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
of 70-100%.
3 Pulse Amplitude 1% to 0.1%. Tested using industry standard simulator.
4
Clinical accuracy based on BCI® 1300;
6
Clinical accuracy based on BCI® 3026;
8 Clinical accuracy based on BCI® 3178;
10
Clinical accuracy based on BCI® 3026;
12
Clinical accuracy based on BCI® 3178;
14 For neonatal patients, 1%-SpO
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.
11-2
)
2
, less than 70% SpO
2
Accuracy in SpO
2
1, 2
Low Perfusion Conditions
±2 A
RMS
±2 A
4
RMS
±3 A
14
RMS
±2 A
5
RMS
±2.5 A
6
RMS
±3.5 A
14
RMS
±3 A
RMS
±2 A
RMS
±2 A
7
RMS
±3.6 A
RMS
±2 A
RMS
±2 A
8
RMS
±2 A
RMS
±2.5 A
RMS
5
Clinical accuracy based on BCI® 1302.
7
Clinical accuracy based on BCI® 3044.
9 Clinical accuracy based on BCI® 1302.
11
Clinical accuracy based on BCI® 3044.
13
Clinical accuracy based on BCI® 1300.
was added to account for theoretical differences in pulse oximetry
2
using human blood
2
is undefined.
2
Accuracy in SpO
2
1, 3
Motion Conditions
±2 9 A
RMS
±2 A
9
RMS
±3 A
14
RMS
±2 A
9
RMS
±2.5 A
10
RMS
±3.5 A
14
RMS
±3 A
RMS
±2 A
RMS
±2 A
11
RMS
±3.6 A
RMS
±2 A
RMS
±2 A
12
RMS
±2 A
RMS
±2.5 A
RMS
of the value measured by
RMS
Clinician's Operation Manual
Accuracy in
2
15
±3 A
RMS
±3 A
13
RMS
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
unspecified
range
2