Integra Codman CereLink Manual Del Usuario página 39

Symbols Used on Labeling
Symbol Title of Symbol
Authorized
Representative in the
European Community
Prescription Use Only
Non-sterile
Protect against Electrical
Static Discharge (ESD)
Refer to instruction
manual / booklet
Date of manufacture
(YYYY-MM-DD)
Caution
Class II or double
insulated electrical
appliance is one which
has been designed
in such a way that
it does not require
a safety connection
to electrical earth
(ground)
Defibrillation-proof
type BF applied part
Meaning of Symbol
Indicates the authorized
representative in the European
Community
Caution: Federal (US) law restricts
this device to sale by or on the
order of a physician or licensed
healthcare practitioner.
Indicates a medical device that has
not been subjected to a sterilization
process.
Graphical Symbols for electrical
equipment in medical practice
To signify that the instruction
manual/booklet must be read.
Indicates the date when the
medical device was manufactured.
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.
Medical electrical equipment - Part
1: General requirements for basic
safety and essential performance
Medical electrical equipment - Part
1: General requirements for basic
safety and essential performance
39
Standard
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
Guidance for Industry: Alternative
to Certain Prescription Device
Labeling Requirements, dated
January 21, 2000
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
IEC TR 60878 2nd Edition 2003-07
ISO 7010 – Graphical symbols
– Safety colors and safety signs –
Registered safety signs
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
BS EN 60601- 1:2006 + A12:2014
BS EN 60601-1:2006 + A12:2014
EN - ENGLISH
Reference
Number
5.1.2
N/A
5.2.7
N/A
M002
5.1.3
5.4.4
9
26