Oximax™ Pulse Oximetry Sensors - Nellcor OXIMAX N-600X Series Service Manual

OxiMax™ Pulse Oximetry Sensors
Pulse Oximetry Sensor Accuracy
1
Subjects used to validate measurement accuracies were healthy and recruited from the local population. Comprised of both men and women,
subjects spanned a range of skin pigmentations and ranged in age from 18-50 years old. Accuracy specifications are based on controlled
hypoxia studies with healthy non-smoking adult volunteers over the specified saturation range(s). Pulse oximeter readings were compared to
SaO2 values of drawn blood samples measured by hemoximetry. All accuracies are expressed as ±1 SD. Pulse oximeter equipment
measurements are statistically distributed; about two-thirds of pulse oximeter measurements can be expected to fall in this accuracy (ARMS)
range. Because scatter and bias of pulse oximeter and blood SaO2 comparison commonly increase as the saturation decreases, and accuracy
specifications are calculated from data spanning the stated range, different accuracy values may result when describing partially overlapping
ranges.
2
Clinical functionality of the MAX-N has been demonstrated on a population of hospitalized neonate patients. The observed 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.
3
Clinical functionality has been demonstrated in a population of hospitalized neonate patients. The observed accuracy was 3.0% in a study of 57
patients with ages of 24 to 40 weeks, weight from 710 to 5,000 grams, and 1 observations made spanning a range of 63% to 99% SaO2.
4
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. 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.
Note:
For a complete listing of SpO2 accuracy across the full line of available OxiMax™ pulse
oximetry sensors, contact 1.800.635.5267.
Sensor Power Dissipation
Pulse Oximetry Sensor
OxiMax MAX-A, -AL, -I, -N, -P, -R
OxiMax Durasensor™ DS-100A
OxiMax OxiCliq™ A, I, N, P
OxiMax Dura-Y™ D-YS
OxiMax Max-Fast™
OxiMax Softcare™ SC-A, -NEO, -PR
Service Manual
To Purchase, Visit Avobus.com
Table 5. Oxygen Saturation Accuracy
LoSAT™ Range
Sensor Model Type 60% to 80%
MAX-A, MAX-AL ± 3.0 digits
2
MAX-N ± 3.0 digits
(Adult and Neonate)
MAX-P, MAX-I, MAX- ± 3.0 digits
FAST
Softcare™ SC-A, -PR, - N/A
3
NEO
MAX-R N/A
4
Low Perfusion N/A
Normal Range 20 to 250 bpm
4
Low Perfusion 20 to 250 bpm
or call 1-800-674-3655
Standard Saturation Range
± 2.0 digits
± 2.0 digits
± 2.0 digits
± 2.0 digits
± 3.5 digits
± 2.0 digits
Pulse Rate
± 3.0 digits
± 3.0 digits
Dissipation
52.5 mW
52.5 mW
52.5 mW
52.5 mW
52.5 mW
52.5 mW
10030881 Rev. B 12-2008
Performance Specifications
1
70% to 100%
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