ZELTIQ CoolSculpting Elite, Руководство пользователя

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System Symbols CoolSculpting® Elite System User Manual
62 CS-UM-CM3-02-EN-D
SYMBOL
STANDARD
REFERENCE STANDARD TITLE
SYMBOL
TITLE
EXPLANATORY TEXT
ISO 7000-2492 Graphical symbols for use
on equipment.
ISO 15223-1,
Clause 5.1.4
Medical devices —
Symbols to be used with
medical device labels,
labelling and information to
be supplied.
Use by
date
Indicates the date after which the
medical device is not to be used.
ISO 7000-2607 Graphical symbols for use
on equipment.
IEC 60601-1,
Table D.2,
Symbol 10
Medical electrical
equipment — Part 1:
General requirements for
basic safety and essential
performance.
Follow
instruction
s for use
Refer to instruction manual/booklet.
ISO 15223-1,
Clause 5.4.3
Medical devices —
Symbols to be used with
medical device labels,
labelling and information to
be supplied.
Consult
instruction
s for use
Indicates the need for the user to
consult the instructions for use.
IEC 60601-1,
Table D.1,
Symbol 11
Medical electrical
equipment — Part 1:
General requirements for
basic safety and essential
performance.
ISO 7000-1641 Graphical symbols for use
on equipment.
ISO 15223-1,
Clause 5.4.4
Medical devices —
Symbols to be used with
medical device labels,
labelling and information to
be supplied.
Caution:
Read all
warnings
and
precautions
in
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.
IEC 60601-1,
Table D.1,
Symbol 10
Medical electrical
equipment — Part 1:
General requirements for
basic safety and essential
performance.
ISO 7000-0434 Graphical symbols for use
on equipment.
IEC 60601-1-
2:2007, Clause
5.1.1
Medical electrical
equipment — Part 1-2:
General requirements for
basic safety and essential
performance — Collateral
standard: Electromagnetic
compatibility —
Requirements and tests
Non-
ionizing
electro-
magnetic
radiation
To indicate generally elevated,
potentially hazardous, levels of
nonionizing radiation, or to indicate
equipment or systems e.g. in the
medical electrical area that include RF
transmitters or that intentionally apply
RF electromagnetic energy for
diagnosis or treatment.
IEC 60417-5140 Graphical symbols for use
on equipment.
IEC 60878-5140
Graphical symbols for
electrical equipment in
medical practice.