Integra Codman CereLink Bedienungsanleitung Seite 41

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
Double insulated
Class II equipment with
functional earthing;
Class II equipment with
functional grounding
(US)
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.
Indicates appliance is 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)
To identify class II equipment with
functional earthing (grounding)
Identifies equipment as a
defibrillation-proof type BF applied
part complying with IEC 60601-1
41
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
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
IEC TR 60878 2nd Edition
IEC 60601-1. Medical Electrical
Equipment- Part 1: General
Requirements for Basic Safety and
Essential Performance
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
IEC 60601-1. Medical Electrical
Equipment- Part 1: General
Requirements for Basic Safety and
Essential Performance
IEC 60417 – Graphical Symbols for
Use on Equipment
IEC 60601-1. Medical Electrical
Equipment- Part 1: General
Requirements for Basic Safety and
Essential Performance
EN - ENGLISH
Reference
Number
5.1.2
N/A
5.2.7
N/A
M002
5.1.3
5.4.4
9
6092
26