Symbols Glossary; Labels And Symbols - Astute Medical ASTUTE140 METER Manual Del Usuario

ASTUTE140 Meter
®

Symbols Glossary

Symbol
IVD
REF
SN
LOT
RFID LOT
Legend for Standard Reference (designation number and title):
a) ANSI/AAMI/ISO 15223-1 & ISO 15223-1 Medical Devices to be used with medical device labels, labeling and information to be supplied —
Part 1: General requirements
b) IEC 60417 DB Graphical Symbols for Use on Equipment
c) ISO 7000 Graphical symbols for use on equipment — Registered symbols
d) Symbol containing explanatory text for clarity
©Astute Medical, Inc. 2020 PN 300153MULTI Rev A 2020/01/07
Standard
Symbol Title
Reference
a Manufacturer
Date for
a
manufacture
Consult instructions
a
for use
In vitro diagnostic
a
medical device
Catalogue
a
number
a Serial number
Humidity
a
limitation
Temperature
a
limit
a Caution
Caution, risk of
b
electric shock
c Biological risks
b Direct Current
Polarity of d.c.
b
power connector
a Batch code
a Use-by date
d RFID Lot
Maintenance and Troubleshooting
Symbol
Symbol Description as Provided
Reference
by the Referenced Standard
Number
Indicates the medical device manufacturer, as defined in EU
5.1.1
Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
5.1.3 Indicates the date when the medical device was manufactured.
Indicates the need for the user to consult the instructions for
5.4.3
use.
Indicates a medical device that is intended to be used as an
5.5.1
in vitro diagnostic medical device.
Indicates the manufacturer's catalogue number so that the
5.1.6
medical device can be identified.
Indicates the manufacturer's serial number so that a specific
5.1.7
medical device can be identified.
Indicates the range of humidity to which the medical device can
5.3.8
be safely exposed.
Indicates the temperature limits to which the medical device
5.3.7
can be safely exposed.
Indicates the need for the user to consult the instructions for
use for important cautionary information such as warnings and
5.4.4
precautions that cannot, for a variety of reasons, be presented
on the medical device itself.
To identify equipment, for example, the welding power source,
6042
that has risk of electric shock.
To indicate a reference to substances that may be hazardous
0659 to men, animals, plants or the environment based on biological
activity (for example, holding a virus)
To indicate on the rating plate that the equipment is suitable for
5031
direct current only; to identify relevant terminals.
To identify the positive and negative connections (the polarity) of
5926 a d.c. power supply, or the positive and negative connections on a
piece of equipment to which a d.c. power supply may be connected.
Indicates the manufacturer's batch code so that the batch or
5.1.5
lot can be identified.
Indicates the date after which the medical device is not to be
5.1.4
used.
— RFID Lot
73