Masimo LNCS-II rainbow DCI 8l SpCO Serie Instrucciones De Uso página 5

Removing the sensor from the patient
1. Open the sensor by pressing on hinge tabs. Remove the sensor from the digit and follow the cleaning instructions, if
necessary.
2. Store the sensor away for its next use.
CLEANING
To clean the sensor, first remove it from the patient and disconnect it from the instrument. You may then clean the sensor by wiping it
with a 70% isopropyl alcohol pad. Allow the sensor to dry prior to placement on a patient.
SPECIFICATIONS
When used with Masimo rainbow SET technology monitors or with licensed Masimo rainbow SET technology modules us-
ing RD/LNC-II rainbow patient cables, the LNCS-II rainbow® DCI and DCIP 8λ SpCO sensors have the following performance
specifications:
Application Site
SpO Accuracy, No Motion
2
SpO Accuracy, Motion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Motion
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, Low Perfusion
SpCO Accuracy, No Motion
SpMet Accuracy, No Motion
NOTE: ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements.
Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.
The Masimo rainbow SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and
1
female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 60%-100% SpO
co-oximeter.
The Masimo rainbow SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and
2
female volunteers with light to dark pigmented skin 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
The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a
3
Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for
saturations ranging from 60% to 100%.
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator
4
and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from
70% to 100%.
SpCO accuracy was determined by testing on healthy adult volunteers in the range of 1%-40% SpCO against a laboratory CO-Oximeter.
5
SpMet accuracy was determined by testing on healthy adult volunteers with light to dark skin pigmentation in the range of 1%-15%
6
MetHb against a laboratory CO-Oximeter.
COMPATIBILITY
These sensors are intended for use only with devices containing Masimo rainbow SET technology or pulse oximetry monitors
licensed to use rainbow compatible sensors. Each sensor is designed to operate correctly only on the pulse oximetry systems
from the original device manufacturer. Use of this sensor with other devices may result in no or improper performance.
For Compatibility Information Reference: www.Masimo.com
Sensor
Weight Range
1
2
3
3
4
3
5
6
against a laboratory co-oximeter.
2
DCI
finger
> 30 kg
60-80% 3%
70-100% 2%
3%
3 bpm
5 bpm
2%
3 bpm
3%
1%
5
DCIP
finger or thumb
10-50 kg
60-80% 3%
70-100% 2%
3%
3 bpm
5 bpm
2%
3 bpm
3%
1%
against a laboratory
2
10572A-eIFU-0220