How Supplied; Clinical Use Information; Disclaimer Of Warranty - Medtronic Micra Nstrucciones De Uso

M953967A_ch.fm 9/25/13 4:13 pm
4.5" x 10.875" (114 mm x 276 mm)
M953967A002D.book Page 6 Wednesday, September 25, 2013 4:13 PM

6 How Supplied

6.1 Sterility
The Micra introducer is individually packaged. It is supplied sterile (electron beam) for single use only.
Do not reuse or attempt to resterilize.
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If the device is damaged or the integrity of the sterilization barrier has been compromised, do not use and
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contact a Medtronic representative for return information.
6.2 Contents
1 Micra introducer with dilator
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1 Instructions for Use document
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6.3 Storage
Store the Micra introducer at room temperature in a dark, dry place to avoid extended exposure to light and
moisture.

7 Clinical Use Information

7.1 Physician Training Requirements
Caution: The Micra introducer should only be used by physicians and teams trained in vascular
interventional techniques and in the use of similar devices.
7.2 Device Inspection
Carefully inspect the device and packaging for damage or defects prior to use. If the Use By date has
elapsed, the device is damaged, or the sterilization barrier has been compromised, do not use the device.
Contact a Medtronic representative for return or replacement.
7.3 Additional Equipment Recommended
0.035 in (0.89 mm) guidewire
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heparinized saline solution
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35 cc or larger syringe
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8 Instructions for Use
1. Remove device from package and ensure that the inner diameter (ID) of the sheath is appropriate for the
maximum diameter of the intravascular device to be introduced.
2. Verify the vessel is of adequate diameter and tortuosity to accommodate the introducer sheath.
3. Open the 3-way valve on the sideport extension.
4. Connect a syringe of heparinized saline solution to the luer fitting on the sideport extension and flush the
sheath, tapping the introducer sheath to aid in releasing air bubbles.
5. Close the 3-way valve on the sideport extension.
6. Connect a syringe of heparinized saline solution to the luer fitting on the dilator and flush the dilator.
7. Insert the dilator completely into the introducer sheath and secure by rotating the dilator grip clockwise,
approximately one-quarter turn.
8. Follow accepted clinical practice for vessel access and guidewire insertion.
9. Activate the hydrophilic coating by wetting the outer surface of the sheath with heparinized saline. Note:
For best results, ensure the device remains wet during placement.
10. Advance the sheath with dilator as a unit over the guidewire under fluoroscopic guidance to the desired
location. Stop advancement if there is resistance and investigate the cause of the resistance before
proceeding.
11. Hold the sheath steady while unlocking and withdrawing the dilator and the guidewire from the sheath
until the dilator and guidewire are completely removed from the sheath.
12. Before removing or inserting devices through the introducer, aspirate at least 30 cc through the side arm
of the valve to clear the introducer of air. Then flush with heparinized saline.
13. Attach a continuous heparinized saline drip to the sideport extension on the introducer to reduce the risk
of thromboembolism.
14. Interventional devices can be interchanged as necessary.
15. Upon removal of the sheath, take precautions to prevent bleeding, vessel damage, or other serious injury.
Advancing the guidewire supported by the dilator into the sheath prior to withdrawing the sheath may aid
in withdrawal from the vasculature.

9 Disclaimer of Warranty

ALTHOUGH THE MICRA INTRODUCER HAS BEEN MANUFACTURED UNDER CAREFULLY
CONTROLLED CONDITIONS, MEDTRONIC, INC., MEDTRONIC VASCULAR, INC. AND THEIR
RESPECTIVE AFFILIATES (COLLECTIVELY "MEDTRONIC") HAVE NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS ALL
WARRANTIES, BOTH EXPRESSED AND IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY FOR ANY
MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY
ANY USE, DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT, WHETHER A CLAIM FOR SUCH
DAMAGES IS BASED UPON WARRANTY, CONTRACT, TORT, OR OTHERWISE. NO PERSON HAS ANY
AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR WARRANTY WITH RESPECT TO
THE PRODUCT.
The exclusions and limitations set out above are not intended to, and should not be construed so as to,
contravene mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held
to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity
of the remaining portions of this disclaimer of warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term
held to be invalid.
M953967A002 Rev D
Medtronic Confidential
6
Refer to document # M953967A for
Printing Instructions.