4
10797B-eIFU-0621
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 products 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.
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.
If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer.
The following symbols may appear on the product or product labeling:
SYMBOL
DEFINITION
SYMBOL
DEFINITION
SYMBOL
DEFINITION
Follow instructions for use
Date of manufacture
YYYY-MM-DD
Caution:
Federal law (USA) restricts
this device to sale by or on the order
of a physician
Consult instructions for use
Lot code
Authorized representative in the
European community
Title: Graphic, Manufacturer Symbol, Masimo
PCX-1986
Revision A
DRO-23934
05/09
Manufacturer
Catalogue number (model number)
Non-Sterile
Use-by YYYY-MM-DD
Masimo reference number
Keep dry
Do not re-use/Single patient use only
≤
Less than or equal to
Do not use if package is damaged and
consult instructions for use
LATEX
PCX-2108A
02/13
Not made with natural rubber latex
Storage temperature range
Greater than
Caution
Storage humidity limitation
Less than
0123
Mark of Conformity to European Medical
Device Directive 93/42/EEC
Atmospheric pressure limitation
Single patient – multiple use
Medical device
Unique device identifier
Importer
Distributor
Instructions/Directions for Use/Manuals are available in electronic format
@ http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
Masimo and NomoLine are federally registered trademarks of Masimo Corporation.
