Insightec Exablate 2100V1 - Page 30

SAFETY
Manual Part Number
30
Symbol
Symbol Title
Description
Standard Reference
Keep dry
Indicates a medical device that needs to be
protected from moisture.
ISO 15223-1: 2016,
clause 5.3.4
Lower limit of
temperature
The lower limit of temperature shall be
indicated adjacent to the lower horizontal
line.
ISO 15223-1: 2016,
clause 5.3.5
Temperature
limit
The upper and lower limits of temperature
shall be indicated adjacent to the upper
and lower horizontal lines.
ISO 15223-1: 2016,
clause 5.3.7
Humidity
limitation
Indicates the range of humidity to which
the medical device can be safely exposed.
ISO 15223-1: 2016,
clause 5.3.8
This way up
This way up
ISO 7000-0623
Do not re-use
Indicates a medical device that is intended
for one use, or for use on a single patient
during a single procedure.
ISO 15223-1: 2016,
clause 5.4.2
IEC 60601-1 Ed 3.1
Table D1 (28)
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
ISO 15223-1: 2016,
clause 5.4.4
IEC 60601-1 Ed 3.1
Table D.1 (10)
General Warning
(There is a certain
danger)
To be placed together with a
supplementary symbol or text.
IEC 60601-1 Ed 3.1
Table D.2 (2)
General
mandatory
action
To be placed together with a
supplementary symbol or text
IEC 60601-Ed 3.1
Table D.2 (9)
Follow
instructions for
use
Refer to instruction manual/ booklet
IEC 60601-Ed 3.1
Corrigendum 1 Table
D.2 (10)