Operator's Manual

Table Of Contents
Radical-7 Chapter 1: Technology Overview
www.masimo.com 36 Masimo
1.
Light Emitting Diodes
(LEDs)
(7 + wavelengths)
2. Detector
Once the Radical-7 receives the signal from the sensor, it utilizes
proprietary algorithms to calculate the patient’s functional oxygen
saturation (SpO
2
[%]), blood levels of carboxyhemoglobin (SpCO [%]),
methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb
[g/dL]) and pulse rate (PR). The SpCO, SpMet and SpHb measurements
rely on a multi-wavelength calibration equation to quantify the
percentage of carbon monoxide and methemoglobin and the
concentration of total hemoglobin in arterial blood. Maximum skin-sensor
interface temperature was tested to be less than 41º C (106º F) in a
minimum ambient temperature of 35º C (95º F). The tests were
conducted with sensors operating at reasonable worst case power.
Pulse CO-Oximetry vs. Drawn Whole Blood Measurements
When SpO
2
, SpCO, SpMet, and SpHb measurements obtained from the
Radical-7 (noninvasive) are compared to drawn whole blood (invasive)
measurements by blood gas and/or laboratory CO-Oximetry methods,
caution should be taken when evaluating and interpreting the results.
The blood gas and/or laboratory CO-Oximetry measurements may differ
from the SpO
2
, SpCO, SpMet, SpHb, and SpOC measurements of the
Radical-7. Any comparisons should be simultaneous, meaning the
measurement on the device should be noted at the exact time that blood
is drawn.