Specifications; Warranty Exclusions - Masimo RD SET-Serie Gebrauchsanweisung

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 with
Masimo Device
Body Weight
Application Site
SpO Accuracy,
2
No Motion (70–100% )
1,5
SpO Accuracy, Motion
2,5
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy,
No Motion (25–240 bpm )
1
Pulse Rate Accuracy, Motion
Pulse Rate Accuracy,
Low Perfusion
3
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
Specification represents clinical study results using Masimo SET Technology under no motion conditions in human blood studies on healthy adult male
1
and female volunteers with light to dark 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
2
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.
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's
3
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
4
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%. Pulse rate accuracy under motion was verified by bench top testing in the range of 45-180 bpm against a Biotek simulator using the motion
preset setting.
Specification reflects use with the following Masimo technology boards and software versions and higher: MS-2000 SB version V5.1, MSX-1 version V5.3,
5
MX-5 version V7.12. For SpO
2
See Bland and Altman. Agreement between methods of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics
*
(2007) vol. 17 pp. 571–582.
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 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.
RD SET Adt RD SET Pdt
> 30 kg 10–50 kg
Finger or Toe Finger or Toe
1.5%
1.5%
3 2%
3 bpm
4 5 bpm
3 bpm
SpO Upper and Lower Limits of Agreement (LoA)*
2
Upper 95% LoA
Lower 95% LoA
of the reference measurements in a controlled study.
rms
accuracy specifications with older versions of Masimo technology boards, refer to individual device operator›s manual.
RD SET Inf
3–10 kg
Thumb or
Great Toe
1.5% 1.5%
1.5% 1.5%
2% 2%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
No Motion
2.3%
-2.3%
6
RD SET Neo
10–20 kg < 3 kg
Hand or
Finger or Toe
Foot
1.5% 3%
1.5% 3%
2% 3%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
Motion
2.9%
-2.2%
against a laboratory co-oximeter.
2
RD SET NeoPt/
NeoPt-500
> 40 kg < 1 kg
Finger or
Hand or Foot
Toe
1.5% 3%
1.5% 3%
2% 3%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
against a laboratory
2
10131B-eIFU-0219