Symbol Legend - BIOTRONIK Galeo Pro Instrucciones De Uso Consejos Para La Instalación

English
4. If desired apply a torque device to the guidewire.
5. Advance the guidewire 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.
6. If a different tip shape is needed, open the haemostatic
valve and flush line on the coronary manifold. Carefully
pull back the guidewire from the guiding catheter. Close
the haemostatic valve and the coronary manifold flush
line.
7. Reshape the guidewire tip according to standard practice
or prepare a new guidewire.
8. Reinsert the guidewire following steps 1 through 5 of this
section.
9. If applied, remove the torque device from the guidewire.
10. Load the interventional cardiology catheter onto the
guidewire by inserting the proximal end of the guidewire
into the distal tip of the interventional cardiology catheter.
11. Hold the guidewire in place while tracking the
interventional cardiology catheter over it and into the
lesion.
Extension Wire
If an extension wire is needed proceed as follows:
1. Carefully remove the Galeo EW from the protective plastic
hoop.
2. Remove the torque device from the Galeo Pro guidewire.
3. Mount the guidewire and the extension wire according to
the Figure 1.
4. Test the security of the guidewire and extension wire
connection. Pull gently to ensure proper connection of
the wires.
5. Prepare the interventional cardiology catheter to be
exchanged.
6. Remove the device over the extension wire and insert the
new interventional cardiology catheter.
7. Advance the interventional cardiology catheter while
maintaining the position of the guidewire and the guiding
catheter.
8. Note: Do not torque or manipulate the extension wire. The
extension wire does not have the torque characteristics of
the Galeo Pro guidewire.
9. Detach the Galeo EW when the exchange is complete.
Make sure that the position of the guidewire will be
unaffected by the maneuver.
Complications
Possible complications include, but are not limited to:
•
Injury to or perforation of the artery wall
•
Hemorrhage or hematoma
•
Infection
•
Embolism
•
Allergic reaction
•
Tip fracture
Warranty/Liability
The product and each component of its system (hereinafter
"the product") have been designed, manufactured, tested and
packaged with all reasonable care. However, Concert Medical
LLC has no control over the conditions under which the product
is used and a disturbance of the intended function of the product
may occur for various reasons. In this respect, the warnings
in this product publication/instructions for use are expressly
to be considered as an integral part of this disclaimer and
provide more detailed information. For this reason, Concert
Medical LLC disclaims all warranties, expressed or implied
regarding the product, including but not limited to, any warranty
of merchantability or fitness for a particular purpose of the
product. Product descriptions or user guidelines in publications
do not constitute any expressed representation or any expressed
or implied warranty. Concert Medical LLC is not liable for any
direct, incidental or consequential damages or medical expenses
caused by any use, defect, failure or malfunction of the product
whether the claim is based on contract, warranty, tort or
otherwise. This does not apply in the case of intention or in the
case of gross negligence of legal representatives or executive
staff of Concert Medical LLC. In commercial transactions relating
to merchants, the liability is limited to the compensation of
typical damages; compensation for any untypical or incidental
damage is excluded. These limitations of liability and warranty
are not intended to contravene any mandatory provisions of
law applicable in the respective country. If any clause of the
disclaimer is considered by a competent court to be invalid or
to be in conflict with the applicable law, the remaining part of
it shall not be affected and remain in full force and effect. The
invalid clause shall be substituted by a valid clause which best
reflects Concert Medical LLC's legitimate interest in limiting its
liability or warranty without infringing any mandatory provisions
of applicable law. No person has any authority to bind Concert
Medical LLC to any warranty or liability regarding the product.

Symbol Legend

Sterilized
I
using ethylene
oxide
D
Do not reuse
Caution,
Y
consult
accompanying
documents
p
Keep Dry

Keep away
from sunlight
r
Temperature
limitation
Do not
resterilize
Figure 1
Galeo Pro Guidewire
Tapered end
4
Do not use
L
if package is
damaged
g
Batch Code
Catalogue
REF
number
H
Use by
i
Instruction
for use
M
Manufacturer
N
Date of
manufacture
Galeo EW
Hypo tube connection