natus Quantum 10-10, Инструкция по эксплуатации

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Symbol
Standard
Reference
Standard Title Symbol Title Explanation
IEC 60601-1
Table D.2 #10 Medical electrical
equipment
— Part 1:
General requirements
for basic safety and
essential performance
Follow instructions for
use Refer to instruction manual/
Booklet.
NOTE on ME EQUIPMENT
"Follow instructions for use”
ISO 15223-1
Symbol 5.4.4 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
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.
IEC 60601-1
Table D.1 #10 Medical electrical
equipment
— Part 1:
General requirements
for basic safety and
essential performance
IEC 60601-1
Table D.2 #2 Medical electrical
equipment
— Part 1:
General requirements
for basic safety and
Essential performance
General warning sign Indicates a hazard of potential
personal injury to patient or
operator.
MDR
2017/745 EU Medical Device
Regulation CE marking Signifies European technical
conformity.
ISO 15223-1
Symbol 5.3.7 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Temperature limit Indicates the (storage)
temperature limits to which the
medical device can be safely
exposed.
ISO 15223-1
Symbol 5.3.8 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Humidity limitation Indicates the range of (storage)
humidity to which the medical
device can be safely exposed.
ISO 15223-1
Symbol 5.3.9
Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Atmospheric pressure
limitation Indicates the acceptable upper and
lower limits of atmospheric
pressure for transport and storage.
034418_02 03/2021