Warranty Exclusions - Masimo RD SET TFA-1 Manual De Instrucciones

SPECIFICATIONS
When used with Masimo SET technology, the RD SET TFA-1 Disposable Transflectance forehead sensors have the following
specifications:
Body Weight
Application Site
SpO Accuracy, No Motion (70–100%)
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Low Perfusion
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 SET Technology has been validated for no motion SpO
1
female 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 low perfusion SpO
2
over a range of 70% to 100% SpO
The Masimo SET Technology has been validated for pulse rate accuracy in bench top testing against a Biotek Index 2 simulator
3
over a range of 25–240 bpm.
COMPATIBILITY
Devices and sensors containing Masimo rainbow SET technology are identified with the Masimo rainbow
SET logo.
Devices and sensors using Masimo SET technology are identified with the Masimo SET logo. These sensors
are for use only with devices containing Masimo SET technology, Masimo SET MS-2000 (Version 4.8.1.1 or
higher) technology or Masimo rainbow SET MX (Version 7.1 or higher) technology.
Each sensor is designed to operate correctly only on the pulse oximetry system from the original equipment manufacturer
(OEM).
Use of this sensor with other devices may result in no or improper performance. Look for the Masimo SET or Masimo rainbow
SET designation on both the sensors and monitors to ensure accurate pulse oximetry when needed most.
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. 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.

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 device 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 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.
TFA-1
1
2
3
2
in bench top testing against a Biotek Index 2 simulator.
2
> 10 kg
Forehead
2%
2%
3 bpm
3 bpm
accuracy in human blood studies on healthy adult male and
2
and pulse rate accuracy with a signal strength of 0.02%
2
5
against a laboratory
2
9508D-eIFU-0319