Specifications - Nonin Onyx Vantage 9590 Instructions For Use Manual

Specifications

Oxygen Saturation Display Range:
Pulse Rate Display Range:
Declared Accuracy:
The tables below show A values measured using the Onyx Vantage 9590 in a clinical study in non-motion conditions.
rms
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact regulatory@nonin.com for accuracy data.
Accuracy Summary by Decade – Finger and Thumb
Decade
70 – 80%
80 – 90%
90 – 100%
70 – 100%
This graph shows plots of the error (SpO
by SaO using the 9590 with a linear regression fit
2
and upper 95% and lower 95% limits of agreement.
Each sample data point is identified by subject
from a clinical study in non-motion conditions.
SpO Low Perfusion Accuracy (A
2
Pulse Rate Declared Accuracy Range (A
Low Perfusion Pulse Rate Declared Accuracy Range (A
Measurement Wavelengths and Output Power**:
Red:
Infrared:
Temperature:
Operating:
Storage/Transportation:
Time (from storage) for monitor to be ready for its intended use: 3 minutes to warm from -40 °C to -5 °C
Humidity:
Operating:
Storage/Transportation:
*± 1 A represents approximately 68% of measurements at zero bias.
rms
**This information is especially useful for clinicians performing photodynamic therapy.
Oxygen Saturation (A )
rms
±2
±2
±2
±2
– SaO )
2 2
*)
rms
*):
rms
*):
rms
0% to 100% SpO
2
18 to 321 beats per minute (BPM)
Accuracy Summary by Decade – Toe
Decade
70 – 80%
80 – 90%
90 – 100%
70 – 100%
This graph shows plots of the error (SpO
by SaO using the 9590 with a linear regression fit
2
and upper 95% and lower 95% limits of agreement.
Each sample data point is identified by subject from
a clinical study using toes in non-motion conditions.
70 to 100% ±2 digits
20 to 250 BPM ±3 digits
40 to 240 BPM ±3 digits
660 nanometers @ 0.8 mW maximum average
910 nanometers @ 1.2 mW maximum average
23 °F to 104 °F / -5 °C to 40 °C
-40 °F to 158 °F / -40 °C to 70 °C
5 minutes to cool from 70 °C to 40 °C
10% to 90% non-condensing
10% to 95% non-condensing
Oxygen Saturation (A )
rms
±2
±3
±3
±3
– SaO )
2 2
5