English
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M-5276-214E
•
The L
ASSO
®
2515 Variable Circular Mapping Catheter is recommended for use with the Biosense Webster P
REFACE
®
Braided Guiding Sheath.
Note: Do not use the
L
ASSO
®
2515 Variable Circular Mapping Catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25mm in diameter.
PRECAUTIONS
•
The catheter should be stored in its original packaging
and in a cool, dry place until it is used.
•
Read all accessory operating instructions prior to connection of the L
ASSO
®
2515 Variable Circular Mapping Catheter.
•
Do not attempt to operate the L
ASSO
®
2515 Variable Circular Mapping Catheter prior to completely reading and understanding these Instructions for Use.
•
Cardiac catheterization procedures should be performed by appropriately trained personnel in a fully equipped electrophysiology laboratory.
•
Careful manipulation must be performed in order to a
void cardiac damage, perforation, or tamponade. Catheter advancement and placement should be done under fluoroscopic
guidance through a guiding sheath. Do not use excessive force to advance or withdraw the catheter through the guiding sheath,
when resistan
ce is encountered. In addition,
extra care should be taken while inserting, aspirating and manipulating the guiding sheath.
•
The sterile packaging and catheter should be inspected prior to use.
•
The L
ASSO
®
2515 Variable Circular Mapping Catheter is intended for single patient use only.
•
Do not resterilize and reuse.
•
This device is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or r
esterilization may compromise the structural integrity
of the de
vice and/or lead to device failure that in turn may result in patient injury, illness or death. Also, reprocessing or resteri
lization of single use devices may create a risk of
contamination 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.
•
Always pull the thumbknob of the catheter back before insertion or withdrawal to assure that the catheter tip assumes its original shape.
•
To avoid char formation on the L
ASSO
®
2515 Variable Circular Mapping Catheter rings, do not apply RF energy when the ablation catheter is in contact with one or mo
re of the
L
ASSO
®
2515 Variable Circular Mapping Catheter electrodes.
“USE BY” DATE
•
This catheter is sterilized with ethylene oxide gas.
•
Do not use if the package is open or damaged.
•
Use the device prior to the “Use By” date on the package label.
DISPOSAL
Recycle components, or dispose o
f the product and its residual elements or waste items in accordance with local laws and regulations.
SUGGESTED INSTRUCTIONS FOR USE
•
Remove the catheter from its package and place it in a sterile work area.
•
Follow standard practice for vessel puncture,
guidewire insertion and guiding sheath use and aspiration per its Instructions for Use.
•
Connect the interface connectors to the appropriate recording equipment.
NOTE: Read pacing and recording equipment operator manual for proper set up and operation.
•
Confirm that the thumbknob is pulled back completely before insertion and that the loop-
contraction mechanism is not activated, ensuring minimal tension to the Nitinol loop.
•
Adjust the loop diameter with the handle grip. By rotating the handle grip to
the right, the loop contracts; by rotating the grip to the left, the loop expands (see Figure 1).
•
Adjust the radius of curvature as necessary by manipulating the thumbknob. Pushing the thumbknob forward causes the catheter tip to bend (curve); when the knob is pulled
back, the tip straightens.
•
Prior to removal of the catheter, confirm that the thumbknob has been pulled back completely and that the loop is in a fully
relaxed position (handle grip rotated fully to the left).
Remove the catheter through th
e guiding sheath and dispose of it in an appropriate manner. Remove the guiding sheath, vessel dilator and guidewire as a uni
t per its
Instructions for Use. Do not resterilize and reuse.
•
If there are any questions regarding the use or performance of this
product, please consult with the local distributor or the manufacturer.
ADVERSE REACTIONS
A number of serious adverse reactions have been documented for cardiac catheterization procedures including pulmonary embolis
m, myocardial infarction, stroke, cardia
c
tamponade, and death.
The following complications associated with cardiac catheterization have also been reported in the literature: vascular bleeding, local hematomas, thrombosis, AV fistula,
pseudoaneurysm, thromboembolism, vasovagal reactions, cardiac perforation, air embolism, arrhythmias, valvular damage, pneumothorax and hemothorax.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
WARNING: This is a controlled proprietary and confidential document.
Release Date: 3/8/2010
