Masimo Radius PPG Mode D'emploi page 6

SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the Radius PPG sensors have the following
specifications:
Radius PPG sensor used with Masimo device
Body Weight
Application Site
SpO Accuracy, No Motion (70–100%
2
SpO Accuracy, Motion
2
2
SpO Accuracy, Low Perfusion
2
Pulse Rate 1 Accuracy, No Motion (25–240 bpm)
Pulse Rate Accuracy, Motion
2
Pulse Rate Accuracy, Low Perfusion
NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the
rms
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 to dark
1
pigmented skin in induced hypoxia studies in the range of 70–100% SpO
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
2
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 low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal
3
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 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%.
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.
5
* See Bland and Altman. Agreement between methods of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics (2007) vol. 17
pp. 571-582.
ENVIRONMENTAL
Storage/Transport Temperature
Operating Temperature
Storage/Transport Humidity
Operating Humidity
BATTERY LIFE
Battery Life
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use Masimo sensors. Radius
PPG sensors are compatible with the following Masimo technology boards and software versions and higher: MX version 7.14.8.x. 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 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
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 MASIMO SENSORS.
Radius PPG Adt Radius PPG Pdt
> 30 kg
Finger or Toe
) 2%
1
3%
2%
3
3 bpm
5 bpm
3 bpm
4
SpO Upper and Lower Limits of Agreement (LoA)*
2
Upper 95% LoA
Lower 95% LoA
of the reference measurements in a controlled study.
rms
0–50°C @ ambient humidity
0–40°C @ ambient humidity
5–95% non-condensing
5–95% non-condensing
96 hours in typical continuous usage
Radius PPG Inf
10–50 kg 3–10 kg
Thumb
Finger or Toe
or Great Toe
2% 2%
3% 3%
2% 2%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
No Motion
1.98%
-2.91%
against a laboratory co-oximeter.
2
against a laboratory co-oximeter.
2
6
Radius PPG Neo
10–20 kg < 3 kg
Finger or Toe Hand or Foot
2% 3%
5
3% 3%
2% 3%
5
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
10352C-eIFU-1219
> 40 kg
Finger or Toe
2%
3%
2%
3 bpm
5 bpm
3 bpm