Operator's Manual

Rad-97 Chapter 15: Specifications
www.masimo.com 200 Masimo
Symbol Description Symbol Description
RS-232 Interface Ethernet
Analog Out Interface USB port
Greater than
China Restriction of
Hazardous Substances
Less than
The names and content of
the
toxic and hazardous
substances or elements shall
be provided in the product
instruction manual
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
Citations
[1] Refer to sensor DFU for specific sensor performance specifications.
[2] SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in
the range 60% to 100% SpO2, 0% to 40% SpCO, and 0% to 15% SpMet against a laboratory
CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging
in age from 7 days to 135 days old and weighing between 0.5 kg and 4.25 kg. Seventy-nine (79)
data samples were collected over a range of 70% to 100% SaO2 and 0.5% to 2.5% HbMet with a
resultant accuracy of 2.9% SpO2 and 0.9% SpMet. Contact Masimo for testing specifications.
[3] The Masimo rainbow SET technology with Masimo 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.
[4] The Masimo rainbow SET technology with Masimo 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 touching
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.
[5] The Rad-97 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%.