Embla Sandman - Environmental Conditions; Pulse Oximeter Performance

Specifications SD32+ System
36
8.8.2. environmental conditions
Usage Temperature +5 °C to +40 °C
Relative Humidity 30% / 75% RH
Atmospheric Pressure 700 / 1060 hPa
Storage Temperature -30 °C to +60 °C (relative humidity up to 95% non-
condensing Pressure 500 / 1060 hPa) Max 15 weeks
8.9. pulse oximeter performance
Measurement Range
SpO2 1% to 100%
Pulse Rate 0 and 20 BPM to 250 BPM
Perfusion Range 0.03% to 20%
Accuracy and Motion Tolerance
Saturation
Without Motion – Adults
9
ximetry.
70 to 100% ± 2 digits
Without Motion – Neonate
5
70 to 100% ± 3 digits
With Motion – Adults and
Neonates
10
70 to 100% ± 2 digits
Low Perfusion
11
70 to 100% ± 2 digits
Averaging Time Changes in SpO2 are reported in 2-3 seconds
Except as indicated, all accuracies are expressed as ± “X” digits between saturations of 70%–
100%. This variation equals ± one standard deviation (1 SD), which encompasses 68% of the
population. Accuracy specifications are based on controlled hypoxia studies with healthy, non-
smoking adult volunteers over the specified saturation SpO
2
range. Pulse oximeter SpO
2
readings were compared to SaO
2
values of drawn blood samples measured by hemo
The above performance specifications are given for the Nellcor
®
OxiMax
®
sensors. For further
information on Nellcor sensors, please visit www.nellcor.com/prod/index.aspx. A full listing of
all sensors and descriptions can be found here including ordering information.
9
Adult specifications are shown for Nellcor OxiMax MAX-A and MAX-N sensors. Neonate specifications are shown for
Nellcor OxiMax MAX-N sensors. Saturation accuracy will vary by sensor type. Refer to the Sensor Accuracy Grid.
10
Applicability: Nellcor OxiMax MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.
11
Specification applies to monitor performance and was validated with Biotek
®
and Nellcor simulators.