BD Alaris - Page 26

Chapter 1—Introduction
12 BD Alaris
TM
System with Guardrails
TM
Suite MX User Manual
Indicates the temperature limits to
which the medical device can be
safely exposed.
Temperature
limit
External
packaging
Ref 5.3.7 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirement
Indicates a medical device that needs
to be protected from moisture.
Keep
dry External
packaging
Ref 5.3.4 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirement
This side up. This way up External
packaging
Ref No.
13 ISO 780
Packaging Distribution
Packaging-Graphical
Symbols for handling
and storage of packages
Indicates a medical device that needs
protection
from light sources.
Keep away from
sunlight
External
packaging
Ref 5.3.2 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirement
Indicates a medical device that can
be broken
or damaged if not handled
carefully.
Fragile, handle
with care
External
packaging
Ref: 5.2.9 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirement
Authorized EC Representative. Authorized
representa
tive in
the European
Community
PCU and all
modules,
(except SpO
2
module),
device labels,
shipping label
(International
only), and
user manual
Ref 5.1.2 ISO 15223-1
Medical devices-
symbols to be used with
medical device labels,
labeling and information
to be supplied – Part 1:
General Requirement
Indicates a medical device that has
been sterilized using ethylene oxide.
St
erilized using
ethylene oxide
Disposable
packaging
Ref 5.2.3 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirement
Symbol
(Graphical
Image)
Definition Symbol Title Symbol
Location
Ref. No. Standard
EC REP