Accutorr Plus™ Operating Instructions
6 - 5
Appendix
Specifications
Interfering Substances:
Carboxyhemoglobin may erroneously
increase readings. The level of increase is
approximately equal to the amount of
carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change
usual arterial pigmentation may cause
erroneous readings.
Pulse Rate Performance Specifications
Pulse Rate During No Motion Conditions
1
:
Adult/Pediatric/Neonates:
26 to 239 BPM ±3 digits
Pulse Rate During Motion Conditions
2,3
:
Adult/Pediatric/Neonates:
26 to 239 BPM ±5 digits
Update Rate:
Less than 4 seconds
1
The Masimo MS-3 pulse Oximetry with
LNOP
®
•Adt sensors have been validated for no
motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies in the range of 70% to 100% SpO
2
against a laboratory co-Oximetry and ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
2
The Masimo MS-3 pulse Oximetry with
LNOP
®
•Adt 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 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% to 100% SpO
2
against a laboratory co-Oximetry and
ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
3
The Masimo MS-3 pulse Oximetry with
LNOP
®
•Neo and
LNOP
®
•NeoPt sensors has
been validated for motion accuracy in human blood studies on neonates while moving the
neonates foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-Oximetry
and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
4
The Masimo MS-3 pulse Oximetry 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 a % transmission of greater than 5% for saturation’s ranging
from 70% to 100%. This variation equals plus or minus one standard deviation. Plus or
minus one standard deviation encompasses 68% of the population.
5
The
LNOP
®
•Ear Sensors have an SpO
2
accuracy of 70% to 100% ±3.5 for adults during
no motion conditions, however, since the monitor cannot display ½ digits, the accuracy
shall be rounded to ±4 digits.
6
The SpO
2
accuracy during motion conditions is not specified for the
LNOP
®
•Ear Sensors.
