Masimo RD SET Serie Manual Del Usario página 6

SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the RD SET Sensors have the following
specifications:
RD Sensor used w/ Masimo Device
Body Weight
Application Site
SpO Accuracy,
2
No Motion (70–100%
SpO Accuracy, Motion
2
SpO Accuracy,
2
Low Perfusion
3
Pulse Rate Accuracy,
1
No Motion (25–240 bpm)
Pulse Rate Accuracy, Motion
Pulse Rate Accuracy,
Low Perfusion
3
NOTE: The A
Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of the measured
rms
values fell within ± the A
rms
1
The Masimo 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 70–100% SpO
2
The Masimo 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
co-oximeter.
3
The Masimo 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%.
4
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 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
The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for the properties of
fetal hemoglobin.
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
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 MERCHANTABILI-
TY 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 AS-
SOCIATED 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
THIS SINGLE-PATIENT SENSOR IS LICENSED TO YOU UNDER THE PATENTS OWNED BY MASIMO FOR SINGLE-PATIENT USE ONLY. BY ACCEPTANCE OR
USE OF THIS PRODUCT, YOU ACKNOWLEDGE AND AGREE THAT NO LICENSE IS GRANTED FOR USE OF THIS PRODUCT WITH MORE THAN A SINGLE
PATIENT.
AFTER SINGLE-PATIENT USE, DISCARD SENSOR. 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 SENSORS.
RD SET Adt
> 30 kg
Finger
or Toe
2%
)
1, 5
3%
2
2%
3 bpm
5 bpm
4
3 bpm
value when compared to the reference device in a controlled study.
RD SET Pdt RD SET Inf
10–50 kg 3 - 10 kg
Finger Thumb or
or Toe Great Toe
2% 2%
3% 3%
2% 2%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
against a laboratory co-oximeter.
2
6
RD SET Neo
10–20 kg < 3 kg
Finger Hand
or Toe or Foot
2% 3%
3% 3%
2% 3%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
RD SET NeoPt/
NeoPt-500
> 40 kg < 1 kg
Finger Hand
or Toe or Foot
2% 3%
3% 3%
2% 3%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
against a laboratory
2
9028F-eIFU-1117