Operator's Manual

Rad-97 Chapter 15: Specifications
www.masimo.com 201 Masimo
[6] Masimo rainbow SET technology with Masimo sensors has been validated for pulse rate
accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator.
[7] 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.
[8] 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.
[9] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument has
been validated for the range of 4 to 70 breaths per minute for adult and pediatric patients and
4 to 120 breaths per minute for infant and neonatal patients in bench top testing. Clinical
validation for up to 61 breaths per minute was also performed with the Masimo Acoustic
Respiration Sensor and Instrument.
[10] 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.
[11] This represents approximate run time with all connectivity options turned off and level 3
screen/key brightness using a fully charged battery.
[12] 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.
[13] 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.
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