Special Considerations; Symbol Glossary - 3M Bair Hugger 11000 Instrucciones De Uso

Special Considerations:

Dual Port for Model 52200/52301 Upper Body Blankets, 54200 Dual
Port Torso Blanket 57000 Surgical Access Blanket
Two hose ports are provided for clinician preference. Place the
removable hose port card in the hose port that is not being used during
warming therapy (see Figure D).
D
Head Drape for Models 54000/54200 Torso Blankets, 52200/52301
Upper Body Blankets and 57000 Surgical Access Blanket
If the patient is intubated and ventilated, lay the head drape over
the patient's head and neck (see figure e) otherwise, tuck the drape
between the channels of the warming blanket, away from the
patient's head.
Warning: Do not allow the warming blanket or head drape
to cover the patient's head or airway when the patient is not
mechanically ventilated.
E
Models 52200/52301 Upper Body Blankets (Optional)
Pull the tie-strip tabs, centered along the upper and lower edges of the
warming blanket. Tie these strips to prevent the inflated blanket from
lifting away from the patient. To use the upper body blanket with one
armboard, one half of the warming blanket can be tied off by wrapping
tape around it or by tucking it beneath the patient (see Figure F).
F
Model 31500 Multi-Access Postoperative and 61000 Full Body
Surgical Blankets
To use the access panels, tear the uncut tab at the edge of the warming
blanket. Remove the backing from the tape strip on the center of the
blanket. Fold the access panel back and press against the exposed
tape. Pull the panel away from the tape to release (see Figure G).
G
Chest drapes for Model 30500 Chest Access Blanket
Raise the clear plastic drape to provide patient care to the upper
body area (see Figure H).
H
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
Authorized
Representative
in European
Community
Batch code
Catalogue
number
Caution
CE Mark
Date of
Manufacture
Do not re-use
Do not use
if package is
damaged or
open
Green Dot
Manufacturer
Medical Device
Natural rubber
latex is not
present
Non Sterile
Unique device
identifier
Use-by date
For more information see, HCBGregulatory.3M.com
Description and Reference
Indicates the authorized
representative in the European
Community. ISO 15223, 5.1.2
Indicates the manufacturer's batch
code so that the batch or lot can be
identified. ISO 15223, 5.1.5
Indicates the manufacturer's
catalogue number so that the
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
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
Union Medical Device Regulation or
Directive.
Indicates the date when the medical
device was manufactured. Source:
ISO 15223, 5.1.3
Indicates a medical device that
is intended for one use or for use
on a single patient during a single
procedure. Source: ISO 15223, 5.4.2
Indicates a medical device that
should not be used if the package
has been damaged or opened.
Source: ISO 15223, 5.2.8
Indicates a financial contribution
to national packaging recovery
company per European Directive
No. 94/62 and corresponding
national law. Packaging Recovery
Organization Europe.
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
Indicates the item is a medical
device.
Indicates natural rubber or dry
natural rubber latex is not present as
a material of construction within the
medical device or the packaging of a
medical device. Source: ISO 15223,
5.4.5 and Annex B
Indicates a medical device that has
not been subjected to a sterilization
process. Source: ISO 15223, 5.2.7
Indicates bar code to scan product
information into patient electronic
health record
Indicates the date after which the
medical device is not to be used.
Source: ISO 15223, 5.1.4
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