8
3M™ Bair Hugger™ Warming Unit Model 775 – Operator’s Manual
Symbol Glossary
Symbol Title
Symbol
Description and Reference
Manufacturer
Indicates the medical device
manufacturer as defined in
Medical Device Regulation
(EU) 2017/745 formerly
EU Directive 93/42/EEC.
Source: ISO 15223, 5.1.1
Authorized
Representative
in European
Community
Indicates the authorized
representative in the
European Community.
Source: ISO 15223, 5.1.2,
2014/35/EU, and/or
2014/30/EU
Date of
Manufacture
Indicates the date when
the medical device was
manufactured. Source:
ISO 15223, 5.1.3
Catalogue number
Indicates the manufacturer’s
catalogue number so that
the medical device can
be identified. Source :
ISO 15223, 5.1.6
Serial number
Indicates the manufacturer’s
serial number so that a
specific medical device
can be identified. Source:
ISO 15223, 5.1 .7
Keep dry
Indicates a medical device
that needs to be protected
from moisture. Source:
ISO 15223, 5.3.4
Consult instructions
for use
Indicates the need for
the user to consult the
instructions for use. Source:
ISO 15223, 5.4.3
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.
Source: ISO 15223, 5.4.4
Medical Device
Indicates the item is a
medical device.
Unique device
identifier
Indicates bar code to scan
product information into
patient electronic health
record
Importer
Indicates the entity
importing the medical
device into the EU.
No Free Hosing
Safety sign indicating no
free hosing
CE Mark
Indicates conformity to all
applicable European Union
Regulations and Directives
with notified body
involvement.
Rx Only
Indicates that U.S. Federal
Law restricts this device to
sale by or on the order of a
healthcare professional. 21
Code of Federal Regulations
(CFR) sec. 801.109(b)(1)
Maximum safe
working load
Indicates the maximum safe
working load in less than
the number reported.
UL Classified
Indicates product was
evaluated and Listed by UL
for the USA and Canada.
Green Dot
Indicates a financial
contribution to national
packaging recovery
company per European
Directive No. 94/62 and
corresponding national
law. Packaging Recovery
Organization Europe.
Follow instructions
for use
To signify that the
instructions for use must be
followed. Source: ISO 7010-
M002
Protective earth;
protective ground
To identify any terminal
which is intended for
connection to an external
conductor for protection
against electric shock in
case of fault, or the terminal
of a protective earth
(ground) electrode. Source:
IEC 60417, 5019
Equipotentiality
To identify the terminals
which, when connected
together, bring the various
parts of an equipment or
of a system to the same
potential, not necessarily
being the earth (ground)
potential. Source: IEC
60417-5021
Fuse
Indicates a replaceable fuse
Recycle electronic
equipment
DO NOT throw this unit into
a municipal trash bin when
this unit has reached the
end of its lifetime. Please
recycle. Source: Directive
2012/19/EC on waste
electrical and electronic
equipment (WEEE)
Type BF applied
part
To identify a type BF
applied part complying with
IEC 60601-1. Source: IEC
60417-5333
For more information see, HCBGregulatory.3M.com