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 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.
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
Follow instructions for use
Consult instructions for use
Manufacturer
Date of Manufacture YYYY-
MM-DD
Use By YYYY-MM-DD
Do not re-use/Single patient
use only
Caution
Federal Communications
Commission (FCC) Licensing
Medical device
Mark of conformity to
European Medical Device
Directive 93/42/EEC
Instructions/Directions for Use/Manuals are available in electronic format
@ http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
Patents: http://www.masimo.com/patents.htm
Masimo, , and Root are federally registered trademarks of Masimo Corporation.
Centroid is a trademark of Masimo Corporation.
SYMBOL
DEFINITION
Separate collection for electrical and
electronic equipment (WEEE).
Lot code
Catalogue number
(model number)
Masimo reference number
Storage humidity Limitation
Do not use if package is damaged and
consult instructions for use
Bluetooth
Identifies unit has been
registered as a radio device
Unique device identifier
Authorized representative in the European
community
5
SYMBOL
Federal law (USA) restricts this device to sale by or
on the order of a physician
Non-sterile
Not made with natural rubber latex
LATEX
Body weight
Storage temperature range
PCX-2108A
02/13
Keep dry
Protection from ingress of particulates and water
spray from any direction
Single patient - multiple use
Importer
Distributor
DEFINITION
9836D-eIFU-0421