Warranty Exclusions - Masimo M-LNCS Mode D'emploi

SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules and patient
cables the YI Sensor has the following specifications:
YI Sensor
Weight Range
SpO Accuracy, No Motion, (70 - 100%)
2
SpO Accuracy, Motion
2
2
SpO Rate Accuracy, No Motion, (25 - 240 bpm)
2
Pulse Rate Accuracy, Motion
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, Low Perfusion
NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements.
rms
Approximately two-thirds of the device measurements fell within +/- A
study.
SpO accuracy was determined by testing on healthy adult volunteers with light to dark skin in the range of 70% -100%
2
SpO against a laboratory co-oximeter. Accuracy specifications are statistically distributed, and only about two-thirds of the
2
measurements fall within the 1 Std. Dev. specification.
The Masimo rainbow SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers
1
with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO
The Masimo rainbow SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with
2
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 Biotek Index 2 simulator
3
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%.
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's
4
simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors
licensed to use YI 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
WARRANTY
Masimo warrants to the initial buyer only that this product, 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.
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.

WARRANTY EXCLUSIONS

This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the
product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any
product that has been connected to any unintended instrument or system, has been modified, or has been disassembled or
reassembled. This warranty does not extend to sensors or patient cables that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR
CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY
THEREOF. IN NO EVENT SHALL MASIMO'S LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT,
WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN
SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED WITH A PRODUCT THAT HAS BEEN
REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY
LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.
NO IMPLIED LICENSE
PURCHASE OR POSSESSION OF THIS SENSOR CONFERS NO EXPRESS OR IMPLIED LICENSE TO USE THE SENSOR WITH ANY
DEVICE WHICH IS NOT SEPARATELY AUTHORIZED TO USE YI SENSORS.
1
3
3
4
4
Neonates Adult / Pediatric / Infants
1 - 3 kg
3%
3%
3 bpm
5 bpm
3%
3 bpm
of the reference measurements in a controlled
rms
against a laboratory co-oximeter.
2
9
>3 kg
2%
3%
3 bpm
5 bpm
2%
3 bpm
against a laboratory co-oximeter.
2
9123F-eIFU-1019