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Specifications
Oxygen Saturation Display Range: 0% to 100% SpO
2
Pulse Rate Display Range: 18 to 321 beats per minute (BPM)
Declared Accuracy:
The table below shows A
rms
values measured using the Onyx II 9550 in a clinical study in non-motion conditions.
SpO
2
Low Perfusion Accuracy (A
rms
*): 70 to 100% ±2 digits
Pulse Rate Declared Accuracy Range (A
rms
*): 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (A
rms
*): 40 to 240 BPM ±3 digits
Measurement Wavelengths and Output Power**:
Red: 660 nanometers @ 0.8 mW maximum average
Infrared: 910 nanometers @ 1.2 mW maximum average
Temperature:
Operating: -5 °C to 40 °C (23 °F to 104 °F)
Storage/Transportation: -40 °C to 70 °C (-40 °F to 158 °F)
Time (from storage) for monitor to be ready for its intended
use:
3 minutes to warm from -40 °C to -5 °C
5 minutes to cool from 70 °C to 40 °C
Humidity:
Operating: 10% to 95% non-condensing
Storage/Transportation: 10% to 95% non-condensing
Altitude:
Operating: Up to 12,192 meters (40,000 feet)
Hyperbaric Pressure: Up to 4 atmospheres
Battery Life:
Operating: Approximately 10,000 spot checks, or 63 hours of continuous
operation using new alkaline batteries.
Storage: 48 months
Classifications per ANSI/AAMI ES60601-1 / CAN/CSA-C22.2 No. 60601-1:
Degree of Protection: Type BF-Applied Part
Enclosure Degree of Ingress Protection: IP33
Mode of Operation: Continuous
This product complies with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing.
This device is not made with natural rubber latex.
*± 1 A
rms
represents approximately 68% of measurements at zero bias.
**This information is especially useful for clinicians performing photodynamic therapy.
This graph shows plots of the error (SpO
2
– SaO
2
) by SaO
2
using the 9550 with a linear regression fit 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.
Accuracy Summary by Decade
Decade Oxygen Saturation (A
rms
)
70 – 80% ±2
80 – 90% ±2
90 – 100% ±2
70 – 100% ±2
6


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