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 O3 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 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
Caution
Use-by
YYYY-MM-DD
Do not re-use/Single patient
use only
Non-Sterile
Not made with natural
LATEX
rubber latex
Single patient - multiple use
Importer
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, , O3, X-Cal, and SET are federally registered trademarks of Masimo Corporation.
SYMBOL
DEFINITION
Separate collection for electrical and
electronic equipment (WEEE).
Lot code
Catalogue number (model number)
Masimo reference number
Greater than
Less than
Storage humidity limitation
Fragile, handle with care
Medical device
Distributor
4
SYMBOL
DEFINITION
Caution: Federal law (USA) restricts
this device to sale by or on the
order of a physician
Mark of conformity to
European Medical Device
Directive 93/42/EEC
Authorized representative in the
European community
Body weight
Storage temperature range
Keep dry
Do not use if package is damaged and
consult instructions for use
Atmospheric pressure limitation
Unique device identifier
Light Emitting Diode (LED)
LED emits light when current flows
X
through
9437E-eIFU-0221