Spo 2 Displayed Saturation Values; Spo₂ Summary Of Clinical Studies Used To Establish Accuracy Claims; Accuracy Of Nellcor ™ Sensors With Oximax ™ Technology; Accuracy Of Masimo Set Technology With Masimo Set Sensors - GE CARESCAPE ONE User Manual

CARESCAPE ONE User Manual DRAFT 26 October 2017
SpO displayed saturation values
2
GE TruSignal, Masimo SET and Nellcor OxiMax pulse oximetry are calibrated to display
functional saturation.
NOTE
SpO₂ summary of clinical studies used to
establish accuracy claims
Accuracy of Nellcor
Accuracy specifications were validated using measurements of healthy non-smoking
adult volunteers during controlled hypoxia studies spanning the specified saturation
ranges. Subjects were recruited from the local population and comprised both men
and women ranging in age from 18-50 years old, and spanned a range of skin
pigmentations. Pulse oximeter SpO
blood samples measured by hemoximetry. All accuracies are expressed as ±1 SD.
Because pulse oximeter equipment measurements are statistically distributed, about
two-thirds of the measurements can be expected to fall in this accuracy (A
Adult specifications are shown for OxiMax MAXA and MAXN sensors with the pulse
oximeter.
Neonate specifications are shown for OxiMax MAXN sensors with the pulse oximeter.
Clinical functionality has been demonstrated on a population of hospitalized neonate
patients. The observed SpO
1 to 23 days, weight from 750 to 4,100 grams, and 61 observations made spanning
a range of 77% to 98% SaO
Accuracy of Masimo SET technology with Masimo SET
sensors
The Masimo SET Technology with Masimo sensors has been validated for no motion
accuracy in human blood studies on healthy adult male and female volunteers with
light to dark skin pigmentation in induced hypoxia studies in the range of 70-100%
SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1
standard deviation. Plus or minus one standard deviation encompasses 68% of the
population.
For detailed information, refer to the supplemental analysis graphs in the appendix
(Bland and Altman. Agreement between methods of measurement with multiple
observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17
pp. 571-582).
2094480-001
You can verify the functionality of pulse oximeter sensor and
monitor with a functional SpO
their accuracy with such a device. For more information,
refer to the standard ISO 80601-2-61:2011-04 Annex FF
(Simulators, calibrators and functional testers for pulse
oximeter equipment).
™ sensors with Oximax
readings were compared to SaO
2
accuracy was 2.5% in a study of 42 patients with ages of
2
.
2
CARESCAPE ONE
Parameter specifications
tester but you cannot evaluate
2
™ technology
values of drawn
2
) range.
RMS
301