5
10102B-eIFU-0920
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
Gas sample
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)
Body weight
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
Medical device
Caution
Storage humidity limitation
Instructions/Directions for
Use/Manuals are available
in electronic format @
http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
0413
Mark of Conformity to
European Medical Device
Directive 93/42/EEC
Atmospheric pressure
limitation
Single patient - multiple
use
Unique device identifier
Patents: http://www.masimo.com/patents.htm
Masimo, NomoLine, and are federally registered trademarks of Masimo Corporation.
