Stryker Synchro2 Gebrauchsanweisung Seite 2

Synchro
2®
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 an ethylene oxide (EO) 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. Used product and any associated
used materials should be handled and processed as biohazardous material.
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 Guidewires are a steerable guidewire family with a
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shapeable tip and are available in straight and pre-shaped versions. The
outside diameters 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 Outer
Diameter
Synchro
2
0.36 mm (0.014 in)
Soft
Synchro
2
0.36 mm (0.014 in)
Standard
Synchro
2
0.36 mm (0.014 in)
Support
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 Outer Recommended
Diameter Catheter ID
0.41 mm
0.36 mm (0.014 in)
(0.016 in) min.
0.41 mm
0.36 mm (0.014 in)
(0.016 in) min.
0.41 mm
0.36 mm (0.014 in)
(0.016 in) min.
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.
Intended User
This device should be used only by physicians trained in percutaneous,
intravascular techniques and procedures.
Contents
One (1) Guidewire
One (1) Torque Device
One (1) Introducer
Intended Patient Population
The Synchro Guidewire series is intended for patients who are candidates for
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endovascular treatment of vascular anomalies.
Clinical Benefits
The Synchro Guidewire is an ancillary device that has an indirect clinical
2
benefit. The clinical benefit consists of its ability to safely introduce and position
catheters and other interventional devices in the neurovasculature or peripheral
vasculature to prevent or treat stroke/infarcts and consequently prevent or
decrease patient clinical consequences of disability. The clinical benefits can be
indirectly measured through overall procedural success (technical success), and
complications/adverse events comparable to the similar devices or alternative
treatments.
For users in the European Union, refer to Summary of Safety and Clinical
Performance report at https://ec.europa.eu/tools/eudamed. Use the following
Basic UDI-DI to search: 08858250000271RL
INTENDED USE/INDICATIONS FOR USE
The Synchro Guidewire series is intended for general intravascular use, including
2
neurovascular and peripheral vasculatures. It can be used to selectively introduce
and position catheters and other interventional devices within the peripheral
and neurovasculature. This device should be used only by physicians trained in
percutaneous, intravascular techniques and procedures.
CONTRAINDICATIONS
The Synchro Guidewire series is not intended for use within the coronary
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vasculature.
If another interventional device is used with the Synchro
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.
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Guidewire, then
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