Warranty Exclusions - Masimo M-LNCS TC-I Mode D'emploi

SPECIFICATIONS
The TC-I Sensor's have the following performance specifications:
When used with:
Sensor
+70 C
Body Weight
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Application Site
NON
STERILE
5%-95% RH
SpO LATEX Accuracy, No Motion (70-100%)
2
95%
%
Pulse Rate Accuracy, No Motion (25-240 bpm)
5%
NOTE: The A
Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68%
rms
of the measured values fell within +/- the A
The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female
1
volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO
co-oximeter.
The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a
2
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%.
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors
licensed to use Masimo 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 M-LNCS SENSORS.
Masimo SET
technology
TC-I
> 30 kg
Ear Lobe
3.5%
1
3 bpm
2
value when compared to the reference device in a controlled study.
rms
Nellcor technology
TC-I
> 30 kg
Ear Lobe
N/A
3 bpm
7
against a laboratory
2
5357F-eIFU-0817