Masimo SET Rainbow SET Rad-57 - Page 57

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 SpO
2,
SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO
2,
0% - 40% SpCO and 0% -
15% SpMet against a laboratory CO-Oximeter. SpO
2
and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135
days old and weighting between 0.5 and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70 - 100% SaO2 and 0.5 - 2.5%
HbMet with a resultant accuracy of 2.9% SpO
2
and 0.9% SpMet. Contact Masimo for testing specifications.
2 The Masimo sensors have 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. This variation equals
plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
3 The Masimo sensors have 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. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
4 The Rad-57 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 transmission of greater than 5% for saturations ranging from 70-100%. This variation equals plus or minus one
standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
5 Masimo sensors have 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
6 This represents approximate run time at lowest indicator brightness, using new, fully charged batteries.
7 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.
8 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.