Masimo Rad-97, Руководство оператора

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Rad-97 Chapter 11: Specifications
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[6] The differences between measurements by the two methods are used to calculate the mean
and standard deviation. The lower 95% limit of agreement is the mean minus 1.96 standard
deviation and the upper 95% limit of agreement is the mean plus 1.96 standard deviation.
These limits are expected to contain 95% of the differences between measurements between
the two methods in controlled environments. Accuracy testing for SpO
2
was performed on
health adult subjects.
[7] SpHb accuracy has been validated on healthy adult male and female volunteers and on
surgical patients with light to dark skin pigmentation in the range of 8 g/dL to 17 g/dL SpHb
against a Coulter Counter. The SpHb accuracy has not been validated with motion or low
perfusion.
[8] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument has
been validated for the range of 4 to 70 respirations per minute in bench top testing. Clinical
validation for up to 30 respirations per minute was also performed with the Masimo Acoustic
Respiration sensor and instrument.
[9] This represents approximate run time with all connectivity options turned off and level 3
screen/key brightness using a fully charged battery.
[10] The battery recharge time shall be no longer than 6 hours at operating temperature of
25°C (77°F) ambient temperature and might not charge completely under elevated ambient
temperature.
[11] If the batteries are to be stored for extended periods of time, it is recommended that they
be stored between -20°C to +30°C, and at a relative humidity less than 85%. If stored for a
prolonged period at environmental conditions beyond these limits, overall battery capacity
may be diminished, and lifetime of the batteries may be shortened.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington.