Masimo RD SET DBI Mode D'emploi page 5

SPECIFICATIONS
The RD DBI sensors have the following specifications:
RD SET DBI Sensor
Body Weight
Application Site
SpO Accuracy, No Motion
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Low Perfusion
NOTE: A
accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-
rms
thirds of the device measurements fell within ± A
The Masimo SET technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light
1
to dark pigmented skin in induced hypoxia studies in the range of 70–100% SpO
The Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's
2
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 pulse rate accuracy for the range of 25–240 bpm in bench top testing against a Biotek Index 2
3
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%.
Not validated for Motion and Low Perfusion accuracy using Nellcor Technology.
4
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use RD SET
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
ENVIRONMENTAL
Operating Temperature
Storage Temperature
Relative Humidity
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 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 RD SET DBI SENSORS.
Masimo SET Technology
Middle or Ring Finger
of the reference measurements in a controlled study.
rms
41°F to 104°F (5°C to 40°C)
-40°F to 158°F (-40°C to 70°C)
10% to 95% noncondensing
> 30 kg
2%
1
2%
2
3 bpm
3
3 bpm
3
against a laboratory CO-Oximeter.
2
5
Nellcor Technology
> 30 kg
Middle or Ring Finger
2%
4
--
3 bpm
4
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9022B-eIFU-0119