Integra Codman ICP EXPRESS Manual De Instrucciones página 16

EN – ENGLISH
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
Prescription Use Only
Magnetic Resonance (MR)
conditional
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.
Indicates a medical device that has not
been subjected to a sterilization process.
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.
Caution: Federal (US) law restricts
this device to sale by or on the order
of a physician or licensed healthcare
practitioner.
An Item with demonstrated safety in
the MR environment within defined
conditions.
Dispose of in accordance with WEEE
regulations.
To indicate the number of devices per
package
11
Standard
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
Guidance for Industry: Alternative to Certain Prescription
Device Labeling Requirements, dated January 21, 2000
ASTM F2503 – Marking Medical Devices and Other Items
for Safety in the Magnetic Resonance Environment
BS EN 50419:2006 – Marking of electrical and electronic
equipment in accordance with Article 11(2) of Directive
2002/96/EC (WEEE)
Proprietary
Reference
Number
5.1.1
5.1.2
5.1.3
5.1.6
5.2.7
5.2.8
5.4.3
5.4.4
M002
N/A
N/A
N/A
N/A