Directions For Use; Symbol Glossary - 3M 54500 Instrucciones De Uso

Directions for Use

Note: In cases where fluid runoff is expected, place an absorbent cloth
beneath the Model 54500 warming blanket.
1. Lay the non-perforated side of the warming blanket (side with
adhesive) on the table. The perforated side (side with small holes)
must be toward the patient in direct contact with the patient's
skin. The head of the warming blanket should extend 6 inches
(15 cm) beyond the table pad. Using the adhesive tape strips on the
underside of the warming blanket, secure the blanket to the table to
prevent it from slipping (Figure A).
A 6" (15 cm)
2. Place the patient on top of the warming blanket while the blanket is
in a non-inflated state.
WARNING: If a securement device (i.e. safety strap, tape) is used,
ensure the warming channels are not occluded.
3. Insert the end of the Bair Hugger warming unit hose into the hose
port (Figures B and C). Use a twisting motion to ensure a snug
fit. A visual marker is located around the mid-section of the hose
end to guide the depth of hose insertion. Support hose to ensure
secure attachment.
WARNING: Do not treat patients with the Bair Hugger hose alone.
Always attach the hose to a Bair Hugger blanket before providing
warming therapy.
B
C
4. Select the desired temperature setting on the warming unit to
initiate warming therapy. (See the Operator Manual for your specific
Warming Unit Model)
CAUTION: Patient Monitoring Recommendations:
• 3M recommends continuously monitoring core temperature. In
the absence of continuous monitoring, monitor the temperature
of patients who are incapable of reacting, communicating and/or
who cannot sense temperature a minimum of every 15 minutes or
according to institutional protocol.
2
Description: 3M™ Bair Hugger™
Item Spec#: 34-8724-6798-9
54500 Adult Underbody Blanket
IFU
Supersedes#:
Base File Name:
Structure#:
PA: 34872467989.indd
GA: GA:
Cat/Product#: 54500
Software: InDesign CC
Reference:
Symbols Updated: All symbols Up-to-date: 10/28/19
Requester: Frank Boeshart
Die # / Doc. Size: 12" x 11" FLAT
LANGUAGE ORDER:
TOTAL # OF
LANGUAGES
IN ORDER FRONT TO BACK: English, French (France), German, Italian, Spanish (Spain), Dutch, Sweden, Danish, Norwegian, Finnish,
Portuguese (Portugal), Greek, Polish, Hungary, Czech, Slovak, Slovenian, Estonian, Latvian, Lithuanian, Romanian, Russian, Croatian,
31
Bulgarian, Serbian, Turkish, Japanese, Chinese Simplifi ed, Arabic, Albanian and Macedonia.
• Monitor cutaneous responses of patients who are incapable
of reacting, communicating and/or who cannot sense
temperature a minimum of every 15 minutes or according to
institutional protocol.
• Adjust air temperature or discontinue therapy when the
therapeutic goal is reached, if elevated temperatures are
recorded or if there is an adverse cutaneous response in the
warmed area.
5. Based on the warming unit model utilized, turn the unit off or
to standby mode to discontinue warming therapy. Disconnect
the hose from the warming blanket and discard the blanket per
hospital policy.
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
Authorized
Indicates the authorized
Representative
representative in the European
in European
Community. ISO 15223, 5.1.2
Community
Indicates the manufacturer's batch
Batch code code so that the batch or lot can be
identified. ISO 15223, 5.1.5
Indicates the manufacturer's
Catalogue catalogue number so that the
number medical device can be identified.
ISO 15223, 5.1.6
Indicates the need for the user to
consult the instructions for use for
important cautionary information
Caution 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
Indicates conformity to European
CE Mark Union Medical Device Regulation or
Directive.
Indicates the date when the medical
Date of
device was manufactured. Source:
Manufacture
ISO 15223, 5.1.3
Indicates a medical device that
is intended for one use or for use
Do not re-use
on a single patient during a single
procedure. Source: ISO 15223, 5.4.2
Do not use Indicates a medical device that
if package is should not be used if the package
damaged or has been damaged or opened.
open Source: ISO 15223, 5.2.8
Indicates a financial contribution
to national packaging recovery
company per European Directive
Green Dot
No. 94/62 and corresponding
national law. Packaging Recovery
Organization Europe.
Indicates the entity importing the
Importer
medical device into the EU.
Indicates the medical device
manufacturer as defined in EU
Manufacturer Directives 90/385/EEC, 93/42/
EEC and 98/79/EC. Source: ISO
15223, 5.1.1
Indicates the item is a medical
Medical Device
device.
Indicates natural rubber or dry
natural rubber latex is not present as Natural rubber
a material of construction within the
latex is not
medical device or the packaging of a
present
medical device. Source: ISO 15223,
5.4.5 and Annex B
Indicates a medical device that has
Non Sterile not been subjected to a sterilization
process. Source: ISO 15223, 5.2.7
Indicates the U.S. Federal Law
restricts this device to sale by or on
Rx Only the order of a physician. 21 Code
of Federal Regulations (CFR) sec.
801.109(b)(1).
Indicates bar code to scan product
Unique device
information into patient electronic
identifier
health record
Indicates the date after which the
Use-by date medical device is not to be used.
Source: ISO 15223, 5.1.4
For more information see, HCBGregulatory.3M.com
12.23.19 Make changes per annotated PDF and fi nal release.
TBD
6" x 11" Folded SIZE
PROCESS
BLACK