6
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 9560 in a clinical study in non-motion conditions.
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:
Infrared:
660 nanometers @ 0.8 mW maximum average
910 nanometers @ 1.2 mW maximum average
Temperature:
Operating:
23 °F to 104 °F / -5 °C to 40 °C
Storage/Transportation:
-40 °F to 158 °F / -40 °C to 70 °C***
Humidity:
Operating:
10% to 95% non-condensing
Storage/Transportation:
10% to 95% non-condensing
Altitude:
Operating:
Up to 40,000 feet / 12,192 meters
Hyperbaric Pressure:
Up to 4 atmospheres
Battery Life:
Operating:
Two 1.5 volt AAA-size batteries power the Model 9560 for approximately
600 spot checks.
Storage:
12 months, minimum
Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1/ UL 60601-1:
Degree of Protection:
Type BF-Applied Part
Enclosure Degree of Ingress Protection:
IP3
2
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.
**This information is especially useful for clinicians performing photodynamic therapy.
*** When the Model 9560 is transferred from a non-operating temperature/humidity condition, allow one hour of stabilization to operating temperature/
humidity specifications prior to use.
Accuracy Summary by Decade
Decade
Oxygen Saturation
(A
rms
)
Low Perfusion Oxygen
Saturation (A
rms
)
70 – 80%
±2
±2
80 – 90%
±2
±2
90 – 100%
±2
±2
70 – 100%
±2
±2
This graph shows plots of the error (SpO
2
– SaO
2
) by SaO
2
using
the 9560 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.
