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
Caution
Do not discard
Fragile, handle with care
Non-sterile
Medical device
Importer
Patents: http://www.masimo.com/patents.htm
Masimo,
, X-Cal, LNCS and SET are federally registered trademarks of Masimo Corporation.
SYMBOL
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
Greater than
Not made with natural
LATEX
rubber latex
Unique device identifier
PCX-2108A
02/13
Distributor
DEFINITION
SYMBOL
5
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
Less than
Atmospheric pressure
limitation
Instructions/Directions for
Use/Manuals are available in
electronic format @ http://
www.Masimo.com/TechDocs
Note: eIFU is not available in all
countries.
5135H-eIFU-0421