
2-16 PRO 100-400 V2 Patient Monitor Service Manual Revision A
2009829-001
Product Description: SECTION 2. PRODUCT DESCRIPTION
Low Perfusion‡ 70 to 100% ±2 digits
0 to 69% unspecified
Pulse Rate
Without Motion 25 to 240 beats/min ±3 digits
With Motion normal physiologic range
25 to 240 beats/min ±5 digits
*The Masimo SET
®
® SpO2 parameter with LNOP-Adt 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% SpO2 against a laboratory co-oximeter and ECG monitor. This variation
equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
**The Masimo SET
®
SpO2 parameter 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 a non
repetitive motion before 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory
co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation
encompasses 68% of the population.
†The Masimo SET
®
SpO2 parameter with LNOP-Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies
on neonates while moving the neonate’s foot at 2 to 4 cm against a laboratory co-oximeter and ECG monitor. This validation equals plus or
minus, one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
‡The Masimo SET
®
SpO2 parameter 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 saturations 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.
Masimo
®
Sensor Accuracy
Sensor Model
SpO2 range 70%- 100%
LNOP ±2 digit
LNOP-ADT ±2 digit
LNOP-ADT Long ±2 digit
LNOP-PDT ±2 digits
LNOP-NEO ±3 digits
LNOP-NEO PT ±3 digits
LNOP-DCI (reusable) ±2 digits
LNOP-DCSC (reusable) ±2 digits
LNOP-DCIP (reusable) ±2 digits
NRI25 (reusable) ±2 digit
Resolution
Saturation (% SpO2) 1%
Pulse Rate (bpm) 1
Low Perfusion Performance
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