19
08.3
–
Symbols, description/ explanation
The different symbols used on product and in this User Manual explained below
Symbol
Description
Meaning
Explanation
Symbol for use in the labelling of
medical devices.
Manufacturer
Indicates the medical device
manufacturer.
Medical electrical equipment
—
Part
1: General requirements for basic
safety and essential performance.
Consult
instructions for
use
Indicates the need for the user to consult
the instructions for use.
Medical electrical equipment
—
Part
1: General requirements for basic
safety and essential performance
Follow
instructions for
use
Refer to instruction manual/booklet.
Medical electrical equipment
—
Part
1: General requirements for basic
safety and essential performance.
Attention: 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, be
presented on the medical device itself.
Medical electrical equipment
—
Type BF applied
part
To identify a type BF applied part
complying with IEC 60601-1.
Medical electrical equipment
—
Part
1: General requirements for basic
safety and essential performance.
Degree of
Ingress
Protection
Provided by
Enclosure
Manufacturer-determined degree of
particle and water ingress protection.
Symbol for use in the labelling of
electrical devices.
In-door use only
To identify electrical equipment designed
primarily for indoor use.
Symbols for use in the labelling of
electrical devices.
Class II
equipment
To identify equipment meeting the safety
requirements specified for Class II
equipment
The requirements for accreditation
and market surveillance relating to
the marketing of products; Medical
Device Directive.
CE marking
Signifies European technical conformity.
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