Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 7-3
7
specifications
COMPLIANCE
EMC Compliance: EN60601-1-2, Class B
Equipment Classification: IEC 60601-1
Type of Protection: Internally powered (on battery power)
Degree of Protection-Patient Cable: Type BF-Applied Part
Mode of Operation: Continuous
1
Masimo Rainbow SET technology with LNOP, LNOPv, LNCS and Rainbow sensors has been validated for no motion
accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation
in induced hypoxia studies in the range of 70-100% SpO
2
against a laboratory CO-Oximeter and ECG monitor.
1% was added to account for the properties of fetal hemoglobin. This variation equals plus or minus one standard
deviation which encompasses 68% of the population.
2
Masimo Rainbow SET technology with LNOP, LNOPv, LNCS and Rainbow sensors has been validated for motion
accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation
in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm
and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range
of 70-100% SpO
2
against a laboratory CO-Oximeter and ECG monitor. 1% was added to account for the properties
of fetal hemoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the
population.
3
Masimo Rainbow SET technology has been validated for low perfusion accuracy in bench top testing against a
Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of
greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation
which encompasses 68% of the population.
4
This represents approximate run time at lowest indicator brightness, using new, fully charged batteries.
5
If alkaline batteries are to be stored for extended periods of time, it is recommended that they be stored between
-0°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.
6
With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging
time may range from 2-4 and 4-6 seconds, respectively.
7
SpCO accuracy has been validated on healthy adult male and female volunteers with light to dark skin pigmentation
in the range of 0% - 40% SpCO against a laboratory CO-Oximeter. This variation equals plus or minus one standard
deviation which encompasses 68% of the population. The SpCO accuracy has not been validated under motion
conditions.
8
SpMet accuracy has been validated on healthy adult male and female volunteers with light to dark skin pigmentation
in the range of 0% - 15% SpMet against a laboratory CO-Oximeter. The variation equals plus or minus one standard
deviation which encompasses 68% of the population. The SpMet accuracy has not been validated under motion
conditions.
9
Masimo Rainbow SET technology with LNOP, LNOPv, LNCS and Rainbow 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. This variation equals
plus or minus one standard deviation which encompasses 68% of the population.
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