Covidien Nellcor OxiMax N-600x Operator's Manual page 176

Specifications
168
1
Saturation accuracy varies by sensor type. Refer to the Sensor
Accuracy Grid at www.covidien.com/rms.
2
Accuracy specifications were validated using measurements of
healthy non-smoking adult volunteers during controlled hypoxia
studies spanning the specified saturation ranges. Subjects were
recruited from the local population and comprised both men and
women ranging in age from 18-50 years old, and spanned a range of
skin pigmentations. Pulse oximeter SpO
SaO values of drawn blood samples measured by hemoximetry. All
2
accuracies are expressed as ±1 SD. Because pulse oximeter equipment
measurements are statistically distributed, about two-thirds of the
measurements can be expected to fall in this accuracy (ARMS) range
(refer to the Sensor Accuracy Grid for more details).
3
Adult specifications are shown for
-
sensors with the N 600x.
4
Neonate specifications are shown for
-
the N 600x.
5
Clinical functionality of the MAX-N sensor has been demonstrated
on a population of hospitalized neonate patients. The observed SpO
accuracy was 2.5% in a study of 42 patients with ages of 1 to 23
days, weight from 750 to 4,100 grams, and 63 observations made
spanning a range of 85% to 99% SaO
6
Specification applies to N-600x oximeter performance. Reading
accuracy in the presence of low perfusion (detected IR pulse
modulation amplitude 0.03% - 1.5%) was validated using signals
supplied by a patient simulator. SpO
varied across the monitoring range over a range of weak signal
conditions and compared to the known true saturation and pulse rate
of the input signals.
7
Motion performance was validated during a controlled hypoxia
blood study over an SaO
2
sample heart rate range of 47-102 bpm. Subjects performed rubbing
and tapping movements 1-2 cm in amplitude with aperiodic intervals
(randomly changing) with a random variation in frequency between
1-4 Hz. The average percent modulation during quiescent periods
was 4.27, during motion 6.91. Motion performance over the entire
specified pulse rate range was validated using synthetic signals from a
patient simulator that comprised representative cardiac and signal
artifact components. Applicability:
MAX-I, and MAX-N sensors.
1
Accuracy
readings were compared to
2
O M -
MAX A and MAX
XI AX
O M
MAX
XI AX
.
2
and pulse rate values were
2
span of 70% to 98% and a convenience-
O M -
MAX A, MAX-AL, MAX-P,
XI AX
N-600x Operator's Manual
-
N
-
N sensors with
2