Specifications
Operator’s Manual Addendum
ADD-27
1.10
Specifications
Product specifications remain the same as those listed in the
Operator’s
Manual
, with the exception of the Nellcor™ Adult Respiratory Sensor data.
Table 1-6.
Nellcor™ Adult Respiratory Sensor Accuracy and Ranges
Measurement Range
Pulse Oximetry Saturation (SpO
2
)
1% to 100%
Pulse Rate
20 to 250 beats per minute (bpm)
Perfusion Range
0.03% to 20%
Respiration Rate
4 to 40 breaths per minute
Pulse Oximetry Saturation (SpO
2
) Accuracy
Population, Condition
Range
Accuracy
Adult
1,
2
70 to 100%
±2 digits
Adult, Low Saturation
1, 2
60 to 80%
±3 digits
Adult, Low Perfusion
3
70 to 100%
±2 digits
Adult, Motion
1, 4
70 to 100%
±3 digits
Pulse Rate Accuracy
Population, Condition
Range
Accuracy
Adult
1, 2
20 to 250 bpm
±3 bpm
Adult, Low Perfusion
3
20 to 250 bpm
±3 bpm
Adult, Motion
1, 4
20 to 250 bpm
±5 bpm
Respiration Rate Accuracy
5
Population
Range
Accuracy
Adult
4 to 40 breaths per minute
±1 breath per minute (Mean Error)
3 breaths per minute (RMSD)
1. SpO2 and pulse rate 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 SpO2 and pulse rate
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).
2. Specifications are shown for the Nellcor™ Adult Respiratory Sensor with the Nellcor™ Bedside Respiratory Patient Monitoring
System.
3. Specification applies to Nellcor™ Bedside Respiratory Patient Monitoring System SpO2 and pulse rate 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.
4. SpO2 and pulse rate performance in motion were 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. The average percent modulation during quiescent periods was 1.63, during motion 4.14. 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.
5. Respiration Rate performance was validated in a hospital study of both men and women ranging in age from 18-91 years old.
Subjects were monitored for 30 minutes on the general care floor. Performance over the entire specified respiration rate range was
validated using synthetic signals from a patient simulator that comprised representative cardiac and signal artifact components.
