Covidien Nellcor GR101704, Service Manual

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Product Specifications
2-4 Service Manual
2.5
Sensor Accuracy and Ranges
This monitoring system has the capability to detect physiological alarm condi-
tions using SpO
2
accuracy, pulse rate accuracy and alarm limit conditions.
Table 2-1. Nellcor™ Sensor Accuracy and Ranges
Measurement Range
SpO
2
1% to 100%
Pulse Rate 20 to 250 beats per minute (bpm)
Perfusion Range 0.03% to 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 48 to 127 bpm ±5 digits
1. Saturation accuracy varies by sensor type. Refer to the Nellcor™ Oxygen Saturation Accuracy Specification 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 (A
RMS
) 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 Nellcor™ Bedside Respiratory Patient Monitoring System.
4. Neonate specifications are shown for OXIMAX MAX-N sensors with the Nellcor™ Bedside Respiratory Patient Monitoring System.
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 Nellcor™ Bedside Respiratory Patient Monitoring System 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. 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. Applicability: OXIMAX MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.