Integra LifeSciences Codman ICP EXPRESS Manual De Instrucciones página 17

Symbol Title of Symbol
Manufacturer
Authorized
representative in the
European Community
Date of manufacture
(YYYY-MM-DD)
Batch code
Catalogue Number
Non-sterile
Do not use if package is
damaged
Consult instructions
for use
Caution
Refer to instruction
manual / booklet
Magnetic Resonance
(MR) conditional
Prescription Use Only
Waste Electrical and
Electronic Equipment
Symbol
Quantity
Meaning of Symbol
Indicates the medical device manufacturer, as
defined in EU Directives 90/385/EEC, 93/42/EEC and
98/79/EC.
Indicates the authorized representative in the
European Community
Indicates the date when the medical device was
manufactured.
Indicates the manufacturer's batch code so that the
batch or lot can be identified.
Indicates the manufacturer's catalogue number so
that the medical device can be identified.
To indicate the product is sold and packaged
nonsterile.
Indicates a medical device that should not be used if
the package has been damaged or opened.
Indicates the need for the user to consult the
instructions for use.
Indicates the need for the User to consult the
instructions for use for important cautionary
information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the
medical device itself.
To signify that the instruction manual/booklet must
be read.
An Item with demonstrated safety in the MR
environment within defined conditions.
Caution: Federal (US) law restricts this device to
sale by or on the order of a physician or licensed
healthcare practitioner.
Dispose of in accordance with WEEE regulations.
To indicate the number of devices per package
ISO 15223-1 Medical Devices – Symbols to be used with
medical device labels, labelling and information to be
supplied
Proprietary
ISO 15223-1 Medical Devices – Symbols to be used with
medical device labels, labelling and information to be
supplied
ISO 7010 – Graphical symbols – Safety colors and safety signs
– Registered safety signs
ASTM F2503 – Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment
Guidance for Industry: Alternative to Certain Prescription
Device Labeling Requirements, dated January 21, 2000
BS EN 50419:2006 – Marking of electrical and electronic
equipment in accordance with Article 11(2) of Directive
2002/96/EC (WEEE)
Proprietary
12
Standard
EN – ENGLISH
Reference
Number
5.1.1
5.1.2
5.1.3
5.1.5
5.1.6
N/A
5.2.8
5.4.3
5.4.4
M002
N/A
N/A
N/A
N/A