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Accuracy of the Lifebox pulse oximeter during hypoxia in healthy volunteers
Author(s) -
Dubowitz G.,
Breyer K.,
Lipnick M.,
Sall J. W.,
Feiner J.,
Ikeda K.,
MacLeod D. B.,
Bickler P. E.
Publication year - 2013
Publication title -
anaesthesia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.839
H-Index - 117
eISSN - 1365-2044
pISSN - 0003-2409
DOI - 10.1111/anae.12382
Subject(s) - medicine , pulse oximetry , food and drug administration , reproducibility , pulse (music) , anesthesia , oxygen saturation , oxygen , statistics , pharmacology , telecommunications , chemistry , mathematics , organic chemistry , detector , computer science
Summary Pulse oximetry is a standard of care during anaesthesia in high‐income countries. However, 70% of operating environments in low‐ and middle‐income countries have no pulse oximeter. The ‘Lifebox’ oximetry project set out to bridge this gap with an inexpensive oximeter meeting CE (European Conformity) and ISO (International Organization for Standardization) standards. To date, there are no performance‐specific accuracy data on this instrument. The aim of this study was to establish whether the Lifebox pulse oximeter provides clinically reliable haemoglobin oxygen saturation (S p O 2 ) readings meeting USA Food and Drug Administration 510(k) standards. Using healthy volunteers, inspired oxygen fraction was adjusted to produce arterial haemoglobin oxygen saturation (S a O 2 ) readings between 71% and 100% measured with a multi‐wavelength oximeter. Lifebox accuracy was expressed using bias (S p O 2 − S a O 2 ), precision ( SD of the bias) and the root mean square error ( A rms ). Simultaneous readings of S a O 2 and S p O 2 in 57 subjects showed a mean ( SD ) bias of −0.41% (2.28%) and A rms 2.31%. The Lifebox pulse oximeter meets current USA Food and Drug Administration standards for accuracy, thus representing an inexpensive solution for patient monitoring without compromising standards.