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SECTION 11: SPECIFICATIONS
Part No. 715-0080, Rev. B
- 93 -
Masimo Sensor Accuracy
4
During No Motion Conditions
5
Oxygen Saturation - Neonates ------------ 70 - 100%
3%
0 - 69%
unspecified
Oxygen Saturation - Pediatrics ------------ 70 - 100%
2%
0 - 69%
unspecified
Pulse Rate - Neonates / Pediatrics ------- 25 - 240 bpm
3 bpm
During Motion Conditions
6,7
Oxygen Saturation - Neonates / Pediatrics ------ 70 - 100%
3%
0 - 69%
unspecified
Pulse Rate - Neonates / Pediatrics ----------- 25 - 240 bpm
5 bpm
Low Perfusion (where 0.02% Pulse Amplitude and % Transmission > 5%)
8
Oxygen Saturation - Neonates / Pediatrics ------------------------
2%
Pulse Rate - Neonates / Pediatrics ----------------------------------
3 bpm
4
Masimo sensors have been validated for pulse rate accuracy for the range of 25 - 240 bpm in bench top testing against
a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation, which encompasses 68% of
the population.
5
Masimo SET technology with LNCS sensors have 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% SpO
2
against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard
deviation, which encompasses 68% of the population. The saturation accuracy of the neonatal sensors was validated
on adult male and female volunteers with light to dark skin pigmentation and 1% was added to account for the
properties of fetal hemoglobin.
6
Masimo SET technology with LNCS 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 a non-repetitive motion between
1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO
2
against a laboratory
co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation, which encompasses 68%
of the population.
7
The Masimo SET Technology with LNCS Neo sensors has been validated for neonatal motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at
2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in
induced hypoxia studies in the range of 70-100% SpO
2
against a laboratory CO-oximeter and ECG monitor. 1% has
been added to the saturation accuracy to account for the effects of fetal hemoglobin. This variation equals plus or
minus one standard deviation, which encompasses 68% of the population.
8
Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2
simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5%
for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation, which
encompasses 68% of the population.
Содержание AirBORNE A750i
Страница 1: ...A750i Transport Incubator Service Manual...
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