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
Serial Number
Do not discard
Non-Sterile
Not made with natural rubber latex
LATEX
Caution
Fragile, handle with care
Protected against solid foreign objects of
1.0 mm diameter and greater and protected
against the effects of temporary immersion
in water
Patents: http://www.masimo.com/patents.htm
Radius PPG and Masimo SafetyNet are trademarks of Masimo Corporation.
Masimo, SET and
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
Light Emitting Diode (LED)
LED emits light when current flows through
X
Greater than
Less than
Storage humidity limitation
Bluetooth
Federal Communications
Commission (FCC) Licensing
Medical device
Protected against solid foreign objects of
12.5 mm diameter and greater and protection
against vertically falling water drops when
enclosure is tilted at 15 degrees
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
Warning
(yellow background)
Identifies unit has been
registered as a radio device
Unique device identifier
Instructions/Directions for Use/Manuals are
available in electronic format @
http://www.Masimo.com/TechDocs
Note: eIFU is not available in
all countries.
10693B-eIFU-0420