3M Bair Hugger 675 - Product Description and Use; Product Description; Indications for Use; Definition of Symbols

8
Proper Use and Maintenance
3M assumes no responsibility for the reliability, performance, or
safety of the temperature warming unit if the following events occur:
• Modifications or repairs are not performed by a qualified, medical
equipment service technician who is familiar with good practice
for medical device repair.
• The unit is used in a manner other than that described in the
Operator’s or Preventive Maintenance Manual.
• The unit is installed in an environment that does not provide
grounded electrical outlets.
• The warming unit is not maintained in accordance with the
procedures described in the Preventive Maintenance Manual
Diagnostics
A qualified service technician can perform over-temperature
detection system testing, temperature output testing, operating
temperature calibration, and error/fault code troubleshooting.
Read Before Servicing Equipment
All repair, calibration, and servicing of the temperature warming unit
require the skill of a qualified, medical equipment service technician
who is familiar with good practice for medical device repair. (No
further 3M warming unit-specific special training, licensing or
certification required for servicing of Model 675 warming unit.) If
service does not require the manufacturer’s attention, the Model 675
Preventive Maintenance Manual provides the technical information
needed to service the unit. Perform all repairs and maintenance
in accordance with the instructions in the Model 675 Preventive
Maintenance Manual For additional service information please
contact 3M Technical Support.
In-Warranty Repair and Exchange
USA:
• Call 3M at 1-800-228-3957 if your Model 675 warming unit
requires factory service.
• Provide the serial number located on the back of the warming
unit.
• Technical Support will give you a Return Authorization (RA)
number. Use this RA number on all correspondence. Your
Technical Support representative will also send a shipping carton
to you at no charge, if needed.
Outside of the USA:
Contact your local distributor concerning in-warranty repair and
exchange. Provide the serial number located on the back of the Bair
Hugger warming unit when you call.
PLEASE REPORT A SERIOUS INCIDENT OCCURRING
IN RELATION TO THE DEVICE TO 3M AND THE
LOCAL COMPETENT AUTHORITY EU OR LOCAL
REGULATORY AUTHORITY.
Symbol Glossary
Symbol Title Symbol Description and Reference
Manufacturer
Indicates the medical device
manufacturer. Source: ISO
15223, 5.1.1
Authorized
Representative
in European
Community /
European Union
Indicates the authorized
representative in the
European Community /
European Union. 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 or consult
electronic
instructions for use
Indicates the need for the user
to consult the instructions for
use. Source: ISO 15223, 5.4.3
Caution
Indicates that caution is
necessary when operating
the device or control close
to where the symbol is
placed, or that the current
situation needs operator
awareness or operator action
in order to avoid undesirable
consequences. Source: ISO
15223, 5.4.4
Medical Device
Indicates the item is a medical
device. Source: ISO 15223,
5.7.7
Unique device
identifier
Indicates a carrier that
contains unique device
identifier information. Source:
ISO 15223, 5.7.10
Importer
Indicates the entity importing
the medical device into the
locale. Source: ISO 15223,
5.1.8
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.
9
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.
Refer to instruction
manual/booklet
To signify that the instruction
manual/booklet
must be read. ISO 7010-
M002
Protective earth
(ground)
To identify any terminal which
is intended for connection
to an external conductor for
protection against electric
shock in case of a 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)
IP Code
Indicates vertically falling
drips shall have no harmful
effects. Source: IEC
60529+AMD1:1999+
AMD2:2013CSV/COR2:2015
Type BF applied
part
To identify a type BF applied
part complying with IEC
60601-1. Source: IEC 60417-
5333
Use only
3Mwarming units
and 3Mwarming
blankets or
gownstogether
Safety sign indicating the Bair
Hugger warming unit Model
675 has been designed to
operate safely ONLY with
3M disposable warming
blankets and gowns. Use with
other products may cause
thermalinjury.
Over-temperature
- Stop use:
Servicerequired
Indicates over-temperature
set point has been reached.
Stop use: Service required
Under-temperature
- Stop use:
Servicerequired
The under-temperature set
point has been reached.
Stop use: Service required
Filter time limit has
beenreached
Indicates that after current
use, the filter should be
changed by service personnel
Powerbutton
(power indicator)
Color indicates the
powerstatus.
Ambient air (Room
temperatureair)
Indicates ambient air (Room
temperature air) set point
Stop use:
Servicerequired
Indicates to stop use and
service is required
For more information see,HCBGregulatory.3M.com