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Idiomas disponibles
Idiomas disponibles
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules and patient cables, during no motion, the saturation accuracy of the M-LNCS, LNCS sensor from 70% to 100% SpO2
is ± 2 digits (1 Std. Dev.) for adults/pediatrics/infants and ± 3 digits (1 Std. Dev.) for neonates. Pulse rate accuracy from 25-300 bpm is ± 3 bpm (1 Std. Dev.) for adults/pediatrics/infants/neonates.
During motion, the saturation accuracy of the M-LNCS, LNCS sensors from 70% to 100% SpO2 is ± 3 digits (1 Std. Dev.) for adults/pediatrics/infants/neonates.The pulse rate accuracy from 25-300 bpm is ± 5 bpm (1 Std. Dev.). Low
perfusion accuracy from 70% to 100% SpO2 is ± 2 digits (1 Std. Dev.) for adults/pediatrics/infants and ± 3 digits (1 Std. Dev.) for neonates and pulse rate accuracy from 25-300 bpm is ± 3 bpm (1 Std. Dev.). The M-LNCS, LNCS se-
ries has been validated with Masimo SET Oximetry Technology. 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.
When used with Nellcor and Nellcor compatible pulse oximeters during no motion, the accuracy of the M-LNCS, LNCS sensors from 70-100% SpO2 is ± 2 digits (1 Std. Dev.) for adults/pediatrics/infants and ±3 digits (1 Std.
Dev.) for neonates. Pulse rate accuracy from 25-240 bpm is ± 3 bpm (1 Std. Dev.). The M-LNCS, LNCS series has been validated on Nellcor's N-200 pulse oximeter.
INSTRUMENT COMPATIBILITY
This sensor is intended for use only with instruments containing Masimo SET oximetry or pulse oximetry monitors licensed to use M-LNCS, LNCS sensors and also with Nellcor and Nellcor compatible pulse oximeters.
Each sensor is designed to operate correctly only on the pulse oximetry systems from the original instrument manufacturer. Use of this sensor with other instruments 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 instrument 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
M-LNCS, LNCS SENSORS.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
The following symbols may appear on the product or product labeling:
SYMBOL
Consult Instructions for Use
Follow Instructions for Use
Manufacturer
Use-by date YYYY-MM-DD
Do not re-use/Single patient use only
Non-sterile
Not made with natural rubber latex
LATEX
Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
Mark of conformity to European medical device directive 93/42/EEC
Keep Dry
Do not use if package is damaged
Fragile, handle with care
Patents: http://www.masimo.com/patents.htm
M-LNCS is a trademark of Masimo Corporation.
Masimo, SET, and LNCS are federally registered trademarks of Masimo Corporation.
Nellcor and OxiMax are federally registered trademark of Nellcor Puritan Bennett Incorporated.
Printed in USA
DEFINITION
SYMBOL
Authorized representative in the European community
Separate collection for electrical and electronic equipment (WEEE).
Lot code
Catalogue number (model number)
Masimo reference number
Body weight
Greater than
Less than
Storage temperature range
Storage humidity limitation
Atmospheric pressure limitation
Instructions/Directions for Use/Manuals are available in electronic format @
http://www.masimo.com/TechDocs
Note: eIFU is not available for CE mark countries.
5
DEFINITION
6698G-eIFU-1016
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