Contraindications - Stryker Neurovascular Synchro-10 Gebrauchsanweisung

Synchro -10
®
Synchro -14
®
Neuro Guidewire with Hydrophilic Coating
ONLY
caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
warnInG
Contents supplied STERILE using a Radiation process. Non-pyrogenic. Do not use
if sterile barrier is damaged. If damage is found, call your Stryker Neurovascular
representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or
lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.
carefUlly reaD all InstrUctIons prIor to Use. to avoID coMplIcatIons,
observe all warnInGs anD precaUtIons DetaIleD tHroUGHoUt tHese
InstrUctIons. faIlUre to Do so May resUlt In coMplIcatIons.
DevIce DescrIptIon
The Synchro Neuro Guidewires are a steerable guidewire family with a
shapeable tip. The outside diameter of the guidewires are listed in the table
below. The guidewires are compatible with existing microcatheters used in
common procedures such as those used in endovascular diagnosis and therapy
of neurovascular disease. The distal portion of the guidewire tip is radiopaque.
Confirm the compatibility of the guidewire diameter with the interventional device
before actual use.
Distal Outside
Synchro-14 0.014 in (0.6 mm)
Synchro-14S 0.014 in (0.6 mm)
Synchro-10 0.010 in (0.5 mm)
For lubricity, the distal portion of the device is coated with a hydrophilic polymer
and the proximal portion of the guidewire is coated with polytetrafluoroethylene
(PTFE).
Proximal Outside
Diameter Diameter
0.014 in (0.6 mm)
0.014 in (0.6 mm)
0.01 in (0.0 mm)
The torque device included with the guidewire attaches to the proximal end of the
wire and functions as a steering guide. Rotation of this device facilitates guidewire
placement into the appropriate vessel by precise directional manipulation of the
guidewire tip.
The introducer included with the guidewire is intended to aid insertion of the
guidewire into the catheter hub and/or hemostasis valve.
contents
This package contains one guidewire, one torque device, and one introducer.
IntenDeD Use/InDIcatIons for Use
The Synchro Neuro Guidewire series is intended for neurovascular use. It can
be used to selectively introduce and position catheters and other interventional
devices within the neurovasculature. This device should be used only by
physicians trained in percutaneous, intravascular techniques and procedures.

contraInDIcatIons

The Synchro Neuro Guidewire series is not intended for use within the coronary
vasculature.
If other interventional devices are used with the Synchro Neuro Guidewire, then
refer to that product labeling for intended use, contraindications and potential
complications associated with the use of that interventional device.
warnInGs
As with all guidewires used in interventional procedures, complications can occur.
Before a guidewire is advanced or withdrawn, verify tip movement under
fluoroscopy to prevent the possibility of vessel perforation or guidewire damage.
Do not 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. Never advance,
auger, withdraw, or torque a guidewire which meets resistance. Resistance may
be felt and/or observed under fluoroscopy by noting any buckling or prolapse of
the guidewire tip. Excessive force against resistance may result in damage to the
guidewire, such as separation of the guidewire tip, damage to the interventional
device, and/or vessel perforation. Determine the cause of the resistance under
fluoroscopy and take any necessary remedial action. The torque device and the
introducer are included to aid in the use of the guidewire and are not intended to
enter the patient's body at any time.
precaUtIons
Confirm the compatibility of the guidewire with the microcatheter before use. The
wire should move freely within the catheter.
Securely fasten the torque device onto the wire to prevent slippage of the torque
device and to avoid product damage (i.e., core wire abrasion/peeling of PTFE, etc.)
Maintain a continuous saline flush between the guiding catheter and the
interventional device and between the interventional device and the guidewire
during the procedure. Flushing prevents contrast crystal formation and/or clotting
on the guidewire and in the catheter lumen.
Verify that package integrity has not been compromised prior to use. Do not use a
product after the expiration date.