Adverse Events; Preparations For Use; Directions For Use; Warranty - Stryker Neurovascular Synchro-10 Gebrauchsanweisung

Inspect the guidewire for any visible damage prior to use, and do not use a wire
that is damaged.
Carefully examine all equipment for defects prior to the interventional procedure.
Do not use any defective equipment.

aDverse events

Clinical complications may result from improper use of the device. Follow
instructions for use carefully. Potential adverse events associated with guidewire
use include, but are not limited to:
• aneurysm perforation/rupture
• death
• embolus
• hemorrhage
• infection
• ischemia
• neurological/intracranial sequelae
• pseudoaneurysm
• stroke
• transient ischemic attack
• vasospasm
• vessel trauma, occlusion, perforation, dissection
• other procedural complications including, but not limited to anesthetic and
contrast media risks, hemodynamic compromise, renal insufficiency, access
site complications
How sUpplIeD
Packaging is designed to maintain sterility according to the expiration date on
the label unless the primary product pouch has been labeled otherwise, opened
or damaged.
Handling and storage
Store in a cool, dry, dark place.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.

preparatIons for Use

1. Flush packaging coil with heparinized saline solution in order to hydrate the
wire coating. Once the product is hydrated, do not allow the product to dry.
. Prior to inserting the guidewire into a catheter, flush the catheter with
heparinized saline solution.
. Carefully remove guidewire from protective packaging coil. Examine prior to
use for evidence of bends, kinks or other damage.
4. Carefully shape the guidewire tip per the following instructions:
A. Hold guidewire introducer or equivalent shaping mandrel in one hand and
rest the guidewire tip across the wire introducer or shaping mandrel at a
90° angle.
B. Gently pinch the guidewire tip between the wire introducer or mandrel
and thumb.
C. Cautiously pull the mandrel toward the guidewire distal tip to implement
shape.
D. Repeat as needed to achieve desired shape.
E. Inspect the shaped tip carefully for any damage. If damaged, do not use the
guidewire.

DIrectIons for Use

1. Carefully insert the guidewire tip into the catheter and advance the guidewire
being careful not to damage the wire tip. The provided guidewire introducer
may be used during the insertion process.
. Put the torque device on the guidewire and position it as required. Tighten it
by twisting the cap.
. Carefully advance and rotate the wire under fluoroscopy to select the
appropriate vessel.
warning: Observe all guidewire movement in the vessels using fluoroscopy.
Do not move or torque a guidewire without observing corresponding
movement of the distal guidewire tip; otherwise, guidewire damage, such as
tip separation, and/or vessel trauma may occur. Always advance or withdraw
the guidewire slowly and carefully.
4. Hold the guidewire in place while tracking the catheter into the selected
vessel site.

warranty

Stryker Neurovascular warrants that reasonable care has been used in the
design and manufacture of this instrument. this warranty is in lieu of and
excludes all other warranties not expressly set forth herein, whether express
or implied by operation of law or otherwise, including, but not limited to, any
implied warranties of merchantability or fitness for a particular purpose.
Handling, storage, cleaning and sterilization of this instrument as well as other
factors relating to the patient, diagnosis, treatment, surgical procedures and other
matters beyond Stryker Neurovascular's control directly affect the instrument and
the results obtained from its use. Stryker Neurovascular's obligation under this
warranty is limited to the repair or replacement of this instrument and Stryker
Neurovascular shall not be liable for any incidental or consequential loss, damage
or expense directly or indirectly arising from the use of this instrument. Stryker
Neurovascular neither assumes, nor authorizes any other person to assume for it,
any other or additional liability or responsibility in connection with this instrument.
stryker neurovascular assumes no liability with respect to instruments reused,
reprocessed or resterilized and makes no warranties, express or implied,
including but not limited to merchantability or fitness for a particular purpose,
with respect to such instruments.
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