ZOLL E Series Monitor Defibrillator Rev H SPO2 - Manual (Page 15)

Specifications
9650-1211-01 Rev. H 13
Specifications
General
Range Oxygen Saturation (% SpO
2
) 1% - 100%
Carboxyhemoglobin Saturation (% SpCO) 0% - 99%
Methemoglobin Saturation (% SpMet)
0% - 99%
Pulse Rate (bpm) 25 - 240 beats per minute
Accuracy Oxygen Saturation (% SpO
2
) - During No Motion Conditions
Adults, Pediatrics
1
70% - 100%, ±2 digits
0% - 69%, unspecified
Neonates
2
70% - 100%, ±3 digits
0% - 69%, unspecified
Oxygen Saturation (% SpO
2
) - During Motion Conditions
3
Adults, Pediatrics 70% - 100%, ±3 digits
0% - 69%, unspecified
Neonates 70% - 100%, ±3 digits
0% - 69%, unspecified
Oxygen Saturation (% SpO
2
) - During Low Perfusion Conditions
4
Adults, Pediatrics 70% - 100%, ±2 digits
Neonates 70% - 100%, ±3 digits
Carboxyhemoglobin Saturation (% SpCO)
5
1% - 40% ±3 digits
Methemoglobin Saturation (% SpMet)
5
1% - 15% ±1 digit
Pulse Rate (bpm) - During No Motion Conditions
1
Adults, Pediatrics, Neonates 25 - 240 ±3 digits
Pulse Rate (bpm) - During Motion Conditions 3
Adults, Pediatrics, Neonates 25 - 240 ±5 digits
Resolution SpO
2
: 1%
SpCO: 1%
SpMet: 0.1% for range up to 9.9%
1% for range 10 - 99%
Pulse rate: 1 bpm (beats per minute)
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.