49
OxyMag_rev26
o
The patient has hypotension, severe vasoconstriction, severe anemia or hypothermia.
o
There is arterial occlusion near the sensor.
o
The patient is in cardiac arrest or shock.
•
The oximetry sensor may be used as long as necessary.
7.2
Summary of Blood Calibration Test
The sensors were clinically validated for motion and no motion conditions on healthy male and female adults with light to dark
skin pigmentation. SpO2 and pulse rate measurements were made for the range of 70 to 100% SpO2.
For the validation of no motion accuracy, hypoxia was induced in the test subjects. Test subjects were monitored with the MS-
11/MS-13 pulse oximetry technology and with an ECG. Blood samples were taken for the range of 70 to 100% SpO2 and
compared against a laboratory CO-oximeter. One percent was added to the accuracies for neonatal sensors to account for
accuracy variation due to properties of fetal hemoglobin.
For the validation of motion accuracy, hypoxia was induced in the test subjects while they were 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.
Test subjects were monitored with the MS-11/MS-13 pulse oximetry technology and with an ECG. Blood samples were taken for
the range of 70 to 100% SpO2 and compared against a laboratory CO-oximeter. One percent was added to the accuracies for
neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin.
7.3
Low perfusion test summary
The sensors were validated for low perfusion accuracy in bench top testing for the range of 70 to 100% SpO2 and a pulse rate in
the range of 30 to 240 bpm. Validation was done with an MS-13 board (integrated into a Masimo SET IntelliVue Module) using
the Biotek Index 2 Simulator with signal strength setting of 0.1%. SpO2 and pulse rate measurements were successfully verified
for + 2% and + 3 beats per minute (bpm) accuracies respectively.
The MS-11/MS-13 boards were validated for signal reception for very low perfusion in bench top testing, using the Masimo
Simulator with signal strength setting of 0.02%. This is a small signal validation, where the board was able to recognize a minimum
of 0.02% signal strength at a fixed SpO2 setting of 83% + 2% and a fixed pulse rate setting of 80 bpm + 2 bpm. The Masimo
Simulator was set at the greatest transmission setting.
7.4
Sensor assembly
Connect the oximetry sensor to the Oxymag as shown in the figure:
