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080118
Medical adhesive
Technical Manual
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician.
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The following list includes trademarks or registered trademarks of
Medtronic in the United States and possibly in other countries. All other
trademarks are the property of their respective owners.
Medtronic
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Description/intended use
Medtronic medical adhesive (Model 080118) is used
as a sealant to minimize the possibility of fluid
entrance.
The medical adhesive is a silicone adhesive.
The Model 080118 is intended for single use only.
Package contents
Dispose of all single-use accessories according to
local environmental requirements. The accessories
are supplied sterile. Each package contains the
following items:
• 1 Tube of medical adhesive
• 1 Applicator
• Product documentation
Contraindications
To date, there are no known contraindications to the
use of medical adhesive.
Warnings and precautions
Note: Medical procedure warnings and precautions
that pertain to the Medtronic implanted system are
provided in the manual that is packaged with the
device or on the Medtronic Manual Library website
(www.Medtronic.com/manuals).
Review the lead documentation – Since the use of
medical adhesive involves working with a pacing lead
or accessory, it is recommended that the lead
documentation be reviewed for all appropriate
warnings, complications, and precautions.
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Sterilization – The medical adhesive has been
sterilized by gamma radiation. The medical adhesive
tube and package have been sterilized by ethylene
oxide prior to shipment. The container should be
inspected prior to opening; if the seal or package is
damaged, discard the medical adhesive tube. The
tube should not be resterilized. It is recommended
that a new sterile tube be used, if necessary.
Instructions for use
To use the medical adhesive, follow these steps:
1. Replace the medical adhesive cap with the
applicator.
2. Insert medical adhesive in the area to be sealed.
3. Wipe away excess medical adhesive.
Medtronic disclaimer of warranty
For complete disclaimer of warranty information, see
the accompanying disclaimer of warranty document.
Service
Medtronic employs highly trained representatives
and engineers located throughout the world to serve
you and, upon request, to provide training to qualified
hospital personnel in the use of Medtronic products.
Medtronic also maintains a professional staff to
provide technical consultation to product users. For
more information, contact your local Medtronic
representative, or call or write Medtronic at the
appropriate telephone number or address listed on
the back cover.
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CE mark of conformity
The following CE mark of conformity applies to the
Model 080118 medical adhesive.
1994
Explanation of symbols
Table 1. Explanation of symbols on package
labeling
Refer to the package labels to see which symbols
apply to this product.
Conformité Européenne (European
Conformity). This symbol means
that the device fully complies with
applicable European Union acts.
For U.S. audiences only
Authorized representative in the
European community
Date of manufacture
Manufacturer
Use by
Lot number
Reorder number
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Table 1. Explanation of symbols on package
labeling (continued)
Serial number
Sterilized using irradiation
Sterilized using ethylene oxide
Do not reuse
Do not use if package is damaged
Upper limit of temperature
Open here
Consult instructions for use at this
website
Package contents
Product documentation
Medical adhesive
Applicator tip
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Medtronic, Inc.
*M971383A001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Authorized Representative
in the European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
Europe/Middle East/Africa
Medtronic International
Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41 21 802 7000
Australia
Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
1800 668 670
Canada
Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
+1 905 460 3800
Technical manuals
www.medtronic.com/manuals
© 2017 Medtronic
M971383A001 A
2017-07-31
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