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Specifications
Oxygen Saturation Display Range:
Pulse Rate Display Range:
Declared Accuracy:
The table below shows A
rms
Accuracy Summary by Decade
Decade
70 – 80%
80 – 90%
90 – 100%
70 – 100%
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:
Humidity:
Operating:
Storage/Transportation:
Altitude:
Operating:
Hyperbaric Pressure:
Battery Life:
Operating:
Storage:
Classifications per ANSI/AAMI ES60601-1 / CAN/CSA-C22.2 No. 60601-1:
Degree of Protection:
Enclosure Degree of Ingress Protection:
Mode of Operation:
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
represents approximately 68% of measurements at zero bias.
rms
**This information is especially useful for clinicians performing photodynamic therapy.
values measured using the Onyx II 9550 in a clinical study in non-motion conditions.
Oxygen Saturation (A
)
rms
±2
±2
±2
±2
*):
rms
*):
rms
0% to 100% SpO
2
18 to 321 beats per minute (BPM)
This graph shows plots of the error (SpO
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.
70 to 100% ±2 digits
20 to 250 BPM ±3 digits
*):
40 to 240 BPM ±3 digits
rms
660 nanometers @ 0.8 mW maximum average
910 nanometers @ 1.2 mW maximum average
-5 °C to 40 °C (23 °F to 104 °F)
-40 °C to 70 °C (-40 °F to 158 °F)
3 minutes to warm from -40 °C to -5 °C
5 minutes to cool from 70 °C to 40 °C
10% to 95% non-condensing
10% to 95% non-condensing
Up to 12,192 meters (40,000 feet)
Up to 4 atmospheres
Approximately 10,000 spot checks, or 63 hours of continuous
operation using new alkaline batteries.
48 months
Type BF-Applied Part
IP33
Continuous
– SaO
) by SaO
2
2
2
6
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