140
Table 1: Accuracy for sensors (Arms) *
* Because SpO
2
measurements are statistically distributed, only about 2/3 of the measurements can be expected to fall within
±
1 Arms of the value measured
by a CO-oximeter
Test methods used to establish SpO
2
accuracy: GE TruSignal SpO
2
measurement have been validated for no motion and motion accuracy in a controlled
hypoxia studies with healthy non-smoking adult volunteers over the specified SpO
2
range. SpO
2
readings were compared to SaO
2
values of drawn blood
samples measured by CO-oximetry. Subjects comprised both adult men and women and spanned a range of skin pigmentation.
** GE TruSignal technology have been validated for low perfusion SpO
2
accuracy over the specified range in a bench top testing against BioTek Index 2 patient
simulator with 0.3% signal amplitude.
GE SpO
2
Sensor
Non motion
(70-100%)
Motion
(70-100%)
Low perfusion
(70-100%)
**
Neonatal
(70-100%)
TS-E-D, TS-E2-GE, TS-E4-GE
±3 digits
unspecified
unspecified
unspecified
TS-SE-3
±2 digits
unspecified
unspecified
±3 digits
TS-F-D, TS-F2-GE, TS-F4-GE, TS-SA-D, TS-SA4-GE
±2 digits
unspecified
±3 digits
unspecified
TS-W-D
±2 digits
unspecified
unspecified
unspecified
TS-AP-10, TS-AP-25
±2 digits
±3 digits
unspecified
unspecified
TS-AF-10, TS-AF-25
±2 digits
±3 digits
unspecified
±3 digits
Summary of Contents for B20
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