Directions For Use - BIOTRONIK Galeo Pro Instrucciones De Uso Consejos Para La Instalación

English
Caution
Federal (USA) law restricts this device to sale by or on the
order of a physician. CAREFULLY READ AND UNDERSTAND
ALL INSTRUCTIONS, INDICATIONS, CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS AND DIRECTIONS FOR USE PRIOR
TO USING THE GUIDEWIRE. FAILURE TO DO SO COULD RESULT
IN COMPLICATIONS.
Description
Galeo Pro coronary guidewires are intended to facilitate the
placement of interventional cardiology catheters with compatible
guidewire lumen during an interventional procedure.
Galeo Pro guidewires have a nominal diameter of 0.014 in.
[0.36mm]; and are provided in nominal lengths of 190cm
and 300cm. The 190cm is extendable by using the Galeo EW
extension wire. The proximal 160 cm shaft is coated with
Polytetrafluoroethylene to enhance insertion and optimize
device tracking. The distal end of the guidewire has two coils,
the proximal stainless steel coil is radiolucent and the distal 26
mm length palladium coil is highly radiopaque. The distal end is
coated with a hydrophilic coating which enhances lubricity and
crossability.
Galeo Pro guidewires are available with different grades of tip
stiffness, high flexible {HF}, flexible {F} or medium {M}, and
with two different shaft types, standard {Std} and extra support
{ES}. The latter offers enhanced tracking and support during
intracoronary stenting procedures.
Indications
Galeo Pro coronary guidewires are intended to facilitate the
placement of interventional cardiology catheters with compatible
guidewire lumen during an interventional procedure.
Contraindications
Galeo Pro coronary guidewires are contraindicated for use in
chronic total occlusions and in the cerebral vasculature. Refer to
instructions for use of the interventional cardiology catheter to
be used with this guidewire for additional contraindications and
potential complications.
Warnings
•
This device is designed for single use only. Do not reuse or
resterilize it, as this may compromise the performance of
the device and increase the risk of complications such as
infection.
•
Prior to use and when possible during the procedure, the
guidewire should be carefully examined for coil separation,
bends, or kinks to verify functionality and ensure that its size
is suitable for the specific procedure for which it is to be used.
•
Do not use a guidewire that shows signs of damage. Damage
will prevent the guidewire from performing with accurate
torque response and control.
•
When the guidewire is in the body, it should be manipulated
while under sufficient and/or high quality fluoroscopy.
•
Always pay attention to the free movement of a guidewire in
a coronary artery. Do not move a guidewire without observing
the resultant tip response.
•
Never push, torque, advance, withdraw or auger the
guidewire against resistance without first determining the
cause of the resistance under fluoroscopy before taking
remedial action. Excessive force against resistance may
cause damage and/or fracture which may result in separation
of the distal tip.
•
If strong resistance is met during manipulation, discontinue
the procedure and determine the cause of the resistance
before proceeding. If the cause of the resistance cannot be
determined, withdraw the entire system.
•
If the tip becomes entrapped within the vasculature or
is fixed, DO NOT TORQUE THE GUIDEWIRE. Advance the
interventional cardiology catheter as distally as possible,
gently pull the guidewire back into the interventional
cardiology catheter, and remove the interventional cardiology
catheter/guidewire system as a unit.
Precautions
•
Do not use the guidewire if the package is damaged or
opened.
•
Use the device prior to the "use by" date on the package
label.
•
Store in a dark, cool and dry location.
•
Use only with water soluble contrast media.
•
Only physicians thoroughly trained and educated in
performing percutaneous transluminal coronary angioplasty
[PTCA] should use this device.
•
Galeo Pro guidewires having a length of 190 cm are
extendable using a Galeo EW as the extension wire. Galeo
Pro guidewires are not compatible with other extension wires
available from other suppliers.

Directions for Use

Using a sterile, aseptic technique, remove the Galeo Pro
guidewire and the protective plastic hoop from the package and
place within the sterile field.
•
To enhance the gliding performances of the Galeo Pro
guidewire, flush the luer lock on the protective plastic hoop
with saline.
•
Remove the white retainer from the guidewire at the inner
window of the protective plastic hoop. Push the proximal
end of the guidewire gently, starting from the inner window,
so that the distal part is being exposed out of the luer lock.
Push until the entire proximal end has disappeared into the
protective plastic hoop. Pull gently at the green guidewire
shaft, which is then protruding out of the luer lock, until the
entire guidewire is removed out of the protective plastic hoop.
•
If needed, shape the guidewire tip carefully according to
standard procedures.
A. Over-the wire type catheters
1. Carefully insert the guidewire through the guidewire
lumen hub in the interventional cardiology catheter.
2. Advance the guidewire until the tip appears just proximal
to the distal tip of the interventional cardiology catheter.
3. Introduce the catheter/guidewire system through the
haemostatic valve on the guiding catheter. Advance
the system until it is proximal to the tip of the guiding
catheter.
4. Tighten the haemostatic valve around the interventional
cardiology catheter; ensure free guidewire movement.
5. If desired, apply a torque device to the guidewire.
6. Advance the guidewire out of the interventional cardiology
catheter and steer it across the lesion. Confirm the
guidewire placement to ensure that the distal tip of the
guidewire is intraluminal in the correct artery.
7. Hold the guidewire in place while tracking the
interventional cardiology catheter over it and into the
lesion.
8. If a different tip configuration or guidewire is needed,
carefully pull back the guidewire from the catheter.
9. Reshape the guidewire tip according to standard practice
or prepare the next guidewire.
10. Reinsert the guidewire following steps 1 through 7 of this
section.
B. Fast-exchange type catheters
1. Apply a guidewire introducer to the haemostatic valve on
the guiding catheter.
2. Carefully advance the distal tip through the guidewire
introducer into the guiding catheter.
3. Remove the guidewire introducer by withdrawing it over
the guidewire. Tighten the haemostatic valve around the
guidewire permitting wire movement.
3