ZOLL X Series Monitor Defibrillator Rev H - Manual (Page 307)

Pulse Oximeter
9650-001355-01 Rev. H X Series Operator’s Guide A-21
SpO
2
Wavelength for LNCS Sensors:
Nominal Red LED Wavelength: 660 nanometers
Nominal Infrared LED Wavelength: 905 nanometers
Energies (Radiant Power) of light for
LNCS Sensors at 50 mA pulsed:
 15 mW
SpO
2
Wavelength for Rainbow Sensors:
The Rainbow sensors use 8 different LEDs with wavelengths of 610 - 905
nanometers
Energies (Radiant Power) of light for
Rainbow Sensors at 100 mA pulsed:
 25 mW
Bio-Compatibility:
Patient contacting material meets requirements of ISO 10993-1, Biological
Evaluation of Medical Device - Part I, for external devices, intact surfaces and
short-term exposure
Environmental:
Operating Temperature: 0 º to 50 º C (32 º to 122 º F)
Storage Temperature: -40 º to 70 º C (-40 º to 158 º F)
Electromagnetic Immunity (SpO
2
Option Only):
AAMI DF-80; EN61000-4-3:2002 to 10 V/m
Note: The X Series Pulse Oximetry Option is calibrated for functional saturation.
1 The Masimo SET ® Technology with LNOP sensors has been validated for no motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 - 100% SpO
2
against a
laboratory CO-oximeter and ECG monitor.
2 The Masimo SET Technology with LNOP sensors has been validated for no motion accuracy in human blood
studies on healthy adult volunteers in induced hypoxia studies in the range of 70 - 100% SpO
2
against a
laboratory CO-oximeter and ECG monitor. 1% has been added to the saturation accuracy to account for the
effects of fetal hemoglobin. This variation equals plus or minus one standard deviation, which encompasses
68% of the population.
3 The Masimo SET Technology with LNOP sensors has been validated for motion accuracy in human blood
studies on healthy adult volunteers 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% has been added to the saturation accuracy to account for the effects of fetal hemoglobin. This
variation equals plus or minus one standard deviation, which encompasses 68% of the population.
4 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a
Biotek Index 2 simulator and a Masimo 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.
5 The Masimo SET Rainbow Technology with Rainbow DC-dc sensors have been validated in human blood on
healthy adult volunteers against a laboratory CO-oximeter from 1 - 40% for carboxyhemoglobin and 1 - 15%
for methemoglobin. This variation equals plus or minus one standard deviation, which encompasses 68% of the
population.