English
8
M-5276-207K
•
Always pull the thumbknob of the catheter back before insertion or withdrawal to assure that the catheter tip assumes its ori
gin
al shape.
•
To place L
ASSO
®
catheter, torque (or rotate) shaft in a clockwise motion only.
“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 t
he package label.
DISPOSAL
Recycle components, or dispose of 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.
•
Confirm that the thumbknob is pulled back completely before insertion. Advance the catheter through the guiding sheath to the area of the endocardium under investigation. Use
both fluoroscopy and electrograms to aid in proper positioning. 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.
•
To place L
ASSO
®
c
atheter,
(or rotate) shaft in a clockwise motion only.
•
Prior to removal of the cathete
r, confirm that the thumbknob has been pulled back completely. Remove the catheter through the guiding sheath and dispose of
it in an
appropriate manner. Remove the guiding sheath, vessel dilator and guidewire as a unit 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 embolism, myocardial infarction, stroke, cardiac
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.
DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, ON THE PRODUCT(S) DESCRIBED HEREIN. UNDER NO CIRCUMSTANCES SHALL BIOSENSE WEBSTER, INC., OR ITS AFFILIATED COMPANIES, BE LIABLE FOR ANY
SPECIAL, DIRECT, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW.
WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS AFFILIATED COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL, DIRECT, INCIDENTAL,
CONSEQUENTIAL, OR OTHER DAMAGES, ARISING OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY APPLICABLE
LAW.
Descriptions and specifications appearing in Biosense Webster Inc. printed matter, including this publication, are informational only and meant solely to generally describe the
product at the time of manufacture and are not made or given as a warranty of the prescribed product in any way.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
Release Date: 6/1/2015
