Accuracy Of Ge Trusignal Technology With Trusignal Sensors; Spo 2 Test Methods Used To Establish Accuracy Claims During Motion - GE CARESCAPE ONE User Manual

CARESCAPE ONE User Manual DRAFT 26 October 2017
Parameter specifications

Accuracy of GE TruSignal technology with TruSignal sensors

The GE TruSignal technology with TruSignal sensors has been validated for no
motion accuracy in controlled hypoxia studies with healthy non-smoking adult
volunteers over the specified saturation SpO
were compared to SaO
co-oximeter. Subjects comprised both healthy adult men and women and spanned a
range of ages and skin pigmentations.
For more 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).
SpO test methods used to establish accuracy
2
claims during motion
Nellcor
™
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
to SaO values of drawn blood samples measured by hemoximetry. All accuracies
2
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
Nellcor ™ sensors motion performance was validated during a controlled hypoxia
blood study over an SaO
range of 41-105 bpm. Subjects performed rubbing and tapping movements 1-2 cm in
amplitude with aperiodic intervals (randomly changing) with a random variation in
frequency between 1-4 Hz. The average percent range was validated using synthetic
signals from a patient simulator that comprised representative cardiac and signal
artifact components. Applicability: OxiMax MAXA, MAXAL, MAXP, MAXI, and MAXN
sensors.
The Masimo SET Technology with Masimo sensors has been validated for motion
accuracy in human blood studies on healthy adult male and female volunteers with
light to dark skin pigmentation in induced hypoxia studies while performing rubbing
and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and non-repetitive
motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in the range of 70% to 100%
SpO against a laboratory CO-oximeter and ECG monitor. This variation equals ±1
2
standard deviation, which encompasses 68% of the population.
NOTE
Measurement modules using GE Ohmeda Technology with TS-AF and TS-AP sensors
have been validated for motion accuracy in controlled hypoxia studies with healthy
non-smoking adult volunteers over the specified saturation SpO
following motion types were used: mechanically induced 3 Hz tapping motion at an
amplitude of 1-2 cm, patient induced non-repetitive rubbing motion, and patient
induced non-repetitive hand motion in supine position. Pulse oximeter SpO
were compared to SaO
302
values of drawn blood samples measured by a laboratory
2
sensors accuracy specifications were validated using measurements of
) range.
RMS
span of 70% to 98.9% and a convenience-sample heart
2
Accuracy during motion has not been specified for Masimo
SET sensors TC-I, TF-I, DBI, Blue, and E-1.
values of drawn blood samples measured by CO-oximetry.
2
CARESCAPE ONE
range(s). Pulse oximeter SpO
2
readings were compared
2
range(s). The
2
readings
2
readings
2
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