natus Nicolet EDX Mode D'emploi page 6

Standard
Symbol
Reference
IEC 60601-1
Table D.2 #10
ISO 15223-1
Symbol 5.4.4
IEC 60601-1
Table D.1 #10
IEC 60601-1
Table D.2 #2
MDR
2017/745
ISO 15223-1
Symbol 5.2.8
ISO 15223-1
Symbol 5.3.7
ISO 15223-1
Symbol 5.3.8
Standard Title
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
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
EU Medical Device
Regulation
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Page 6 of 6
Symbol Title
Follow instructions for Refer to instruction manual/
use Booklet.
NOTE on ME EQUIPMENT
"Follow instructions for use"
Caution 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.
General warning sign Indicates a hazard of potential
personal injury to patient or
operator.
CE marking Signifies European technical
conformity.
Do not use if package Indicates a medical device that
is damaged should not be used if the package
has been damaged or opened.
Temperature limit Indicates the (storage)
temperature limits to which the
medical device can be safely
exposed.
Humidity limitation Indicates the range of (storage)
humidity to which the medical
device can be safely exposed.
Explanation
033126_03 02/2021