natus Aurical HIT, User Manual, Page: 22 / 28

ISO 15223-
1:2016 Refer-
ence no.
5.2.8. (ISO
7000-2606) Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be sup-
plied. Do not use if pack-
age is damaged Indicates a medical device that
should not be used if the package
has been damaged or opened and
that the user should consult the
instructions for use for additional
information
ISO 15223-
1:2016
Reference no.
5.4.2. (ISO
7000- 1051)
Medical devices —
Symbols to be used
with medical device
labels, labeling, and
information to be sup-
plied – Part 1: Gen-
eral requirements. Do not re-use Indicates a medical device that is
intended for one single use only
NOTE: Synonyms for “Do not
reuse” are “single use” and “use
only once”.
ISO 15223-
1:2016 Refer-
ence no.
5.4.3. (ISO
7000-1641) Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be sup-
plied. Consult instruc-
tions for use Oper-
ator's manual;
operating instruc-
tions Indicates the need for the user to
consult the instructions for use
ISO 15223-1,
Clause 5.4.4
ISO 60601-1
Table D.1 sym-
bol 10
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be sup-
plied.
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential per-
formance.
Caution: Read all
warnings and pre-
cautions 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 reas-
ons, be presented on the medical
device itself.
IEC 60601-1,
Table D.2 sym-
bol 2 Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential per-
formance. General warning
sign 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 reas-
ons, be presented on the medical
device itself.
22 Aurical HIT
9 Definition of symbols