Technical Data
96
✽1 This device is calibrated to functional oxygen saturation.
✽2 SpO
2
measurement accuracies were validated with healthy recruited volunteers from the local popula-
tion. Subjects comprised both men and women ranging in age from 18-50 years old, and spanned a
range of skin pigmentations. Accuracy specifications are based on controlled hypoxia studies with
healthy non-smoking adult volunteers over the specified SpO
2
range(s). Pulse oximeter SpO
2
readings
were compared with SaO
2
values of drawn blood samples measured by hemoximetry. All accuracies are
expressed as ±1SD. Pulse oximeter equipment measurements are statistically distributed; about two-
thirds of pulse oximeter measurements are expected to fall in this accuracy (Arms) range. Because
scatter and bias of pulse oximeter SpO
2
and blood SaO
2
comparison commonly increase as the satura-
tion decreases, and accuracy specifications are calculated from data spanning the stated range, differ-
ent accuracy values may result when describing partially overlapping ranges.Pulse rate from SpO2 was
compared to ECG heart rate.
✽3 Reading accuracy in the presence of low perfusion (detected IR pulse modulation amplitude 0.03-1.5%)
were validated using signals supplied by a patient simulator. SpO
2
and pulse rate values were varied
across the monitoring range over a range of weak signal conditions and compared with the known true
saturation and pulse rate of the input signals.
✽4 The materials accessible to the patient and the user comply with ISO 10993-1.
✽5 All the sensors and patient cables that can be used with this device have been tested and verified by us-
ing the Nellcor/NELL-1 module pulse oximeter technology.
✽6 Even if the power supply is interrupted due to power failure, disconnection of the power plug or some
other cause, the preselected settings will be retained in the memory. When the power supply is re-
sumed, the unit will start operation with the last selected settings.
✽
7
Alarm delays should not exceed 10 seconds other than as specified in this manual.
■ Humidity
This unit is not equipped with humidity control.
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