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
Caution
Use-by
YYYY-MM-DD
+70 C
Do not re-use/Single
patient use only
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-Sterile
NON
STERILE
5%-95% RH
Not made with natural
LATEX
LATEX
rubber latex
95%
Single patient -
%
multiple use
5%
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, SET, X-Cal, RD SET and
SYMBOL
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
are federally registered trademarks of Masimo Corporation.
DEFINITION
SYMBOL
10
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
X
flows through
10497A-eIFU-1220