English - ev3 Avigo Instrucciones

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Instructions for Use
Avigo™ Hydrophilic Guidewire
CAUTION
• Federal (USA) law restricts this device to sale by or on the order of a physician.
• This device should be used only by physicians with a thorough understanding of angiography and
percutaneous interventional radiologic procedures.
• Do not use if pouch is open or damaged.
CONTENTS
One (1) sterile, hydrophilic guidewire with torque device and guidewire introducer.
DESCRIPTION
The Hydrophilic Guidewire is a stainless steel core wire with a radiopaque, distal segment. The guidewire is
hydrophilically coated on the distal portion.
Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire
introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
INDICATIONS FOR USE
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of
catheters in the peripheral and cerebral vasculature during diagnostic and/or therapeutic procedures. The
device is not intended for use in the coronary arteries.
The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional
procedures.
The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a
hemostasis valve.
CONTRAINDICATIONS
• The .014" wire with distal polymer jacket is not DMSO compatible.
WARNINGS
• This device is intended for single use only. Discard the product after use. Structural integrity and/or
function may be impaired through reuse or cleaning.
• Never advance or withdraw the guidewire against resistance until the cause of the resistance is
determined by fluoroscopy. Do not attempt to move the guidewire without observing the resultant
tip response.
PRECAUTIONS
• Prior to use, carefully examine the guidewire and its packaging to verify no damage has occurred
during shipment. Do not use if pouch is open or damaged.
• Inspect the guidewire for any surface irregularities, bends or kinks. Any guidewire damage may
decrease the desired performance characteristics. Avoid exposure of the guidewire coating to
disinfection agents such as alcohols. This may result in coating delamination.
• The hydrophilic coating bonded to the guidewire is an extremely lubricious surface when properly
hydrated. Ensure proper hydration by allowing entire guidewire to become wet for at least 30 seconds
prior to use.
• Neither the guidewire introducer nor the torque device is intended to enter the body.
• To prevent damage to the guidewire coating, manipulate the guidewire using the torque device at
proximal end of the guidewire.
STORAGE
This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C).
POTENTIAL COMPLICATIONS
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar
with the possible complications, which may occur during or after the procedure.
Possible complications include, but are not limited, to the following:
• Perforation of vessel or arterial wall
• Puncture site hematoma
• Infection
COMPATIBILITY
The guidewire is compatible with other ancillary products used in intravascular procedures. Any over-the-
wire style of micro catheter used with the guidewire should have at least 0.0025" (0.06 mm) clearance
between the lumen of catheter and the guidewire.
• Thrombus formation
• Vasospasm
• Ischemia
PREPARATIONS FOR USE
EN
1. Before removing the guidewire from the protective coil, use a 20 cc syringe to fill the coil with saline
and allow the guidewire to hydrate for at least 30 seconds.
2. Carefully remove the guidewire from the protective coil.
3. Inspect the guidewire thoroughly to make certain that it is not kinked or otherwise damaged.
4. Prior to inserting the guidewire into the catheter, flush the catheter lumen with saline to provide
smooth movement of the guidewire within the catheter.
5. If desired, the distal tip of the guidewire can be carefully shaped to the desired configuration.
DIRECTIONS FOR USE
1. When introducing the guidewire into the catheter and introducer sheath, ensure that at least 5
centimeters of guidewire extends from the most proximal hub. This will keep the guidewire from
slipping down inside the catheter. Refer to Figure 1 for illustration of catheter/guidewire set-up.
2. To aid in the selective placement of the catheter into a particular vessel, gently rotate the proximal end
of the guidewire as it is advanced forward.
3. Between uses, place the guidewire in a basin of saline, or fill the packaging coil with saline and replace
the guidewire between uses. Avoid wiping down with damp cloth, particulate from the cloth can
adhere to the surface of the guidewire.
4
Figure 1: Recommended Set-up
Line to flush solution
(300mmHg)
Syringe
3-Way Stopcock
RHV
Catheter Hub
RHV
Torque Device
Line to flush solution
(300mmHg)
Syringe
3-Way Stopcock