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