Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE
Refer to the appropriate product for symbols that apply.
Symbol
Title
Explanation
Standard
Reference
Manufacturer
Medical device manufacturer, as
defined in EU Directive 93/42/EEC
ISO 15223-1
5.1.1
Date of manufacture
Date when the medical device was
manufactured.
ISO 15223-1
5.1.3
Use-by date
Date after which the medical device
is not to be used.
ISO 15223-1
5.1.4
Batch code
Manufacturer’s batch code so that
the batch or lot can be identified.
ISO 15223-1
5.1.5
Catalogue number
Manufacturer’s catalogue number so
that the medical device can be
identified.
ISO 15223-1
5.1.6
Do not use if package is
damaged
Medical device should not be used if
the package has been damaged or
opened.
ISO 15223-1
5.2.8
Keep away from sunlight
A medical device that needs
protection from light sources.
ISO 15223-1
5.3.2
Keep dry
A medical device that needs to be
protected from moisture.
ISO 15223-1
5.3.4
Temperature limit
The temperature limits to which the
medical device can be safely
exposed.
ISO 15223-1
5.3.7
Humidity limitation
Indicates the range of humidity to
which the device can be safely
exposed
ISO 15223-1
5.3.8
Atmospheric pressure
limitation
Indicates the range of atmospheric
pressure to which the device can be
safely exposed
ISO 15223-1
5.3.9
Do not re-use
A medical device that is intended for
one use, or for use on a single
patient during a single procedure.
ISO 15223-1
5.4.2
Consult instructions for use
Indicates the need for the user to
consult the instructions for use.
ISO 15223-1
5.4.3
Refer to instruction
manual/booklet.
Indicates the instruction
manual/booklet must be read. (This
symbol is blue and white on the
device label)
ISO 7010:2011
M002
Caution
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.
ISO 15223-1
5.4.4
