Covidien Nellcor Series, Руководство оператора

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Product Specifications
11-6 Operator’s Manual
4
Neonate specifications are shown for OxiMax™ MAXN sensors with the monitoring system.
5
Clinical functionality of the MAXN sensor has been demonstrated on a population of hospital-
ized 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 monitoring system 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 mon-
itoring 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 modula-
tion 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™ MAXA,
MAXAL, MAXP, MAXI, and MAXN sensors.
Table 11-5. Nellcor™ Sensor Operating Ranges and Power Dissipation
Operating Range and Dissipation
Red Light Wavelength Approximately 660 nm
Infrared Light Wavelength Approximately 900 nm
Optical Output Power Less than 15 mW
Power Dissipation 52.5 mW