Specifications; Warranty Exclusions - Masimo DBI-Serie Bedienungsanleitung

SPECIFICATIONS

DBI Series Reusable Soft Sensors have the following specifications:
When Used with:
DBI Sensor
+70 C
Body Weight
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Application Site
NON
STERILE
5%-95% RH
SpO Accuracy, No Motion
2
LATEX
SpO Accuracy, Low Perfusion
2
95%
%
Pulse Rate Accuracy, No Motion
5%
Pulse Rate Accuracy, Low Perfusion
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
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 low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal
2
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
3
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 DBI 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 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 DBI SENSORS.
LNCS
> 30 kg
Middle or ring finger
2% 1
2%
2
3 bpm
3 bpm
of the reference measurements in a controlled study.
rms
Masimo SET Technology
Direct Connect
Red Direct Connect
> 30 kg
Middle or ring finger
3 bpm
3
3 bpm
2
against a laboratory CO-Oximeter.
2
5
Nellcor Technology
Middle or ring finger
2% 1
2%
2
3
2
LNCS
> 30 kg
3% 4
---
3 bpm
4
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6684C-eIFU-0518