Vapotherm Oxygen Assist Module, Инструкция по эксплуатации

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Page 22 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Section 19 Specifications
Masimo SET
®
Accuracy Specifications
Saturation (% SpO
2
) – During No Motion Conditions1
Adults, Pediatrics 70% - 100% ± 2 digits
0% - 69% unspecified
Neonates 70% - 100% ± 3 digits
0% - 69% unspecified
Saturation (% SpO
2
) – During No Motion Conditions2,3
Adults, Pediatrics 70% - 100% ± 3 digits
0% - 69% unspecified
Neonates 70% - 100% ± 3 digits
0% - 69% unspecified
Pulse Rate (bpm) – During No Motion Conditions1
Adults, Pediatric, Neonates 25 to 240 ± 3 digits
Pulse Rate (bpm) – During Motion Conditions2,3
Adults, Pediatric, Neonates 25 to 240 ± 5 digits
1 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% SpO
2
against a laboratory CO-Oximeter and ECG monitor. This variation equals ±1standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
2 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 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 ±1 standard deviation, which encompasses
3 The 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 transmission of greater than 5% for saturations
ranging from 70 to 100%. This variation equals ±1 standard deviation. Plus or minus one standard deviation encompasses 68%
of the population.
4 The Masimo SET Technology with Masimo Neo sensors has been validated for neonatal 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 ±1 standard deviation. Plus or minus one standard deviation encompasses 68% of the
population. 1% has been added to the results to account for the effects of fetal hemoglobin present in neonates.
5 The Masimo SET technology with Masimo sensors has 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 ±1 standard deviation. Plus or minus one standard
deviation encompasses 68% of the population.
6 See sensor directions for use (DFU) for complete application information. Unless otherwise indicated, reposition reusable
sensors at least every 4 hours and adhesive sensors at least every 8 hours.
11 Sensor accuracy specified when used with Masimo technology using a Masimo patient cable for LNOP sensors, RD SET
sensors, the LNCS sensors, or the M-LNCS sensors. Numbers represent Arms (RMS error compared to the reference). Because
pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall
within a range of ± Arms compared to the reference value. Unless otherwise noted, SpO
2
accuracy is specified from 70% to
100%. Pulse Rate accuracy is specified from 25 to 240 bpm.
12 Masimo M-LNCS, LNOP, RD SET, and LNCS sensors types have the same optical and electrical properties and may differ
only in application type (adhesive/non-adhesive/hook & loop), cable lengths, optical component locations (top or bottom of sensor
as aligned with cable), adhesive material type/size, and connector type (LNOP 8 pin modular plug, RD 15 pin modular plug,
LNCS 9 pin, cable based, and M-LNCS 15 pin, cable based). All sensor accuracy information and sensor application instructions
are provided with the associated sensor directions for use.
References
For Vapotherm Precision Flow specifications, see the Precision Flow Instructions for Use.
For SpO
2
sensor specification, see the documentation provided with the sensor.