GE Portrait Hub01, Руководство пользователя

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Parameter specifications
SpO
2
displayed saturation values
Portrait TM pulse oximetry technology is calibrated to display functional saturation.
NOTE
You can verify the functionality of pulse oximeter sensor
and monitor with a functional SpO
2
tester but you cannot
evaluate their accuracy with such a device. For more
information, refer to the standard ISO 80601-2-61:2017 Annex
FF (Simulators, calibrators and functional testers for pulse
oximeter equipment).
SpO₂ summary of clinical studies used to
establish accuracy claims
Accuracy of Portrait TM sensor technology
The Portrait technology with Portrait sensors P-SA01, P-SP01, P-SE01, and P-W01 has
been validated for no motion accuracy in controlled hypoxia studies with healthy
non-smoking adult volunteers over the specified saturation SpO
2
range(s). Pulse
oximeter SpO
2
readings were compared to SaO
2
values of drawn blood samples
measured by a laboratory 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 (Bland and
Altman. Agreement between methods of measurement with multiple observations per
individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582).
SpO
2
test methods used to establish accuracy claims during
motion
Portrait
TM
technology with Portrait sensors P-SA01, P-SP01, P-SE01, and P-W01
has been validated for motion accuracy in controlled hypoxia studies with healthy
non-smoking adult volunteers over the specified saturation SpO
2
range(s). The
motion artifact was induced by the subject and was non-repetitive with frequency
varying between 1 to 5Hz. The following motion types were used: tapping motion,
rubbing/clenching motion with hand in prone and supine positions. The infrared signal
amplitude in motion periods was in average 2.5 times the signal amplitude in no
motion periods. Pulse oximeter 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 pigmentations.
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Portrait ™ Mobile Monitoring Solution
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