7
7532E-eIFU-0218
SPECIFICATIONS
The sensors are indicated as follows:
Sensor
R1 25L
R1 25/R1 25L
R1 20
R1 20L
Application Site
Hand or foot
Finger
Finger
Thumb or great
toe
Finger or toe
Weight Range
< 3 kg
7
> 30 kg
10 - 50 kg
3 - 10 kg
10 - 30 kg
Saturation Accuracy, No Motion
1
(70 - 100%)
2%
2%
2%
2%
2%
Saturation Accuracy, No Motion
1
(60 - 80%)
---
3%
3%
3%
3%
Saturation Accuracy, Motion
2
3%
3%
3%
3%
3%
Pulse Rate Accuracy, No Motion
3
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
Pulse Rate Accuracy, Motion
3
5 bpm
5 bpm
5 bpm
5 bpm
5 bpm
Low Perfusion Accuracy, Saturation
4
2%
2%
2%
2%
2%
Low Perfusion Accuracy, Pulse Rate
4
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
SpMet Accuracy, No Motion
5
1%
1%
1%
1%
1%
SpHb Accuracy, o Motion
6
---
1 g/dL
1 g/dL
1 g/dL
1 g/dL
A
rms
accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds
of the device measurements fell /-
A
rms
of the reference measurements in a controlled study.
1
The Masimo rainbow SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers
with light to dark pigmented skin in induced hypoxia studies in the range of 60%-100% SpO
2
against a laboratory co-oximeter.
2
The Masimo rainbow SET technology has been validated for motion accuracy in human blood studies on healthy adult male and 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
2
against a laboratory
CO-Oximeter.
3
The Masimo rainbow SET technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a 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 70%
to 100%.
4
The Masimo rainbow SET technology 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 transmission of greater than 5% for saturations ranging from 70% to 100%.
5
SpMet accuracy was determined by testing on healthy adult volunteers with light to dark skin pigmentation in the range of 1% - 15% MetHb against a
laboratory CO-Oximeter.
6
SpHb accuracy from 8 to 17 g/dL is ± 1 g/dL for adults/pediatrics/infants.
7
SpO
2
and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135 days old and weighing between 0.5 and 4.25 kgs.
Seventy-nine (79) data samples were collected over a range of 70-100% SaO
2
and 0.5 - 2.5% MetHb with a resultant neonatal accuracy of 2.9% SpO
2
and
0.9% SpMet.
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET with rainbow 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 instruments may result in no or improper performance.
For Compatibility Information Reference: www.Masimo.com
WARRANTY
Masimo warrants to the initial buyer only that these products, when used in accordance with the directions provided with the
Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products are
warranted for single patient use only.
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER.
MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO’S SOLE OBLIGATION AND BUYER’S
EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO’S OPTION, TO REPAIR OR REPLACE THE PRODUCT.
