Covidien Nellcor OxiMax N-600x, Operator'S Manual

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Performance Specifications
Operator’s Manual
123
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 SpO2 readings were compared to SaO2 values of drawn blood samples
measured by hemoximetry. All 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 OXIMAX MAX-A and MAX-N sensors with the N-600x.
4
Neonate specifications are shown for OXIMAX MAX-N sensors with the N-600x.
5
Clinical functionality of the MAX-N sensor has been demonstrated on a population of hospitalized neonate
patients. The observed SpO2 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% SaO2.
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. SpO2 and pulse rate values were 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 SaO2 span of 70% to 98%
and a convenience-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:
OXIMAX
MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.
Note:
For a complete listing of SpO2 accuracy across the full line of available OxiMax™ pulse
oximetry sensors, contact 1.800.635.5267.
Table 20. Accuracy
1
Saturation
Adult
2, 3
70 to 100% ±2 digits
Adult and Neonate Low Sat
2, 3, 4
60 to 80% ±3 digits
Neonate
4, 5
70 to 100% ±2 digits
Low Perfusion
6
70 to 100% ±2 digits
Adult and Neonate with Motion
2, 7
70 to 100% ±3 digits
Pulse Rate
Adult and Neonate
2, 3, 4
20 to 250 bpm ±3 digits
Low Perfusion
6
20 to 250 bpm ±3 digits
Adult and Neonate with Motion
2, 7
20 to 250 bpm ±5 digits