rSO2 Accuracy (Arms*): 50% to 100% rSO2
rSO2 accuracy testing was conducted during induced hypoxia studies on male and female, over 18 years of age, healthy, light- to dark-skinned subjects in an independent research laboratory. The measured regional hemoglobin saturation value (rSO2) of the sensors was compared to arterial/venous hemoglobin oxygen (SavO2) value, determined from venous and arterial blood samples. The model used for blood in the brain was 70% venous and 30% arterial, which is applicable under normocapnic conditions. The venous blood was drawn from the right jugular bulb. The accuracy of the sensors in comparison to the blood gas analyzer samples measured over the rSO2 range of 45–100%. Accuracy data was calculated using the root-meansquared (Arms value) for all subjects, per ISO 80601-2-61:2011, Medical Electrical Equipment—Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Inter/Intra Sensor Repeatability Accuracy: ±2 digits (Arms*)
Operating: -5 °C to 40 °C (23 °F to 104 °F)
Storage/Transportation: -30 °C to 70 °C (-22 °F to 158 °F)
Device temperature will not exceed 41 °C as measured during a controlled environment test.
Operating: 10 % to 90 % non-condensing
Storage/Transportation: 10 % to 95 % non-condensing
* ±1 Arms encompasses 68% of the population at zero bias.
Magnetic Field Strength (8006PI):
Less than 1 gauss (0.1T) at a distance of 12cm.
Measurement Wavelengths and Output Power**
730 nanometers @ 3.0 mW maximum average power
760 nanometers @ 4.5 mW maximum average power
810 nanometers @ 3.2 mW maximum average power
880 nanometers @ 4.5 mW maximum average power
** This information is especially useful for clinicians performing photodynamic therapy.
This product complies with ISO 10993-1.
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