English
M-5276-207K
7
L
ASSO
®
Deflectable Circular Mapping Catheter
•
STERILE. Sterilized using ethylene oxide.
•
For one single use only.
•
Do not autoclave.
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Do not use if the package is open or damaged.
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CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
CATHETER DESCRIPTION
The Biosense Webster
L
ASSO
®
Deflectable Circular Mapping Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart. It is deployed in the rig
ht
or left atrium through an 8
F guiding sheath, similar to Biosense Webster's
P
REFACE
®
Guiding Sheaths. This deflectable catheter
consists of a 3
F circular spine on its distal tip, with
platinum electrodes that can be used for stimulation and recording. Models are available with different circular spine diameters. By pushing forward on the catheter thumbknob, the
tip is deflected; when the thumbknob is pulled back, the catheter tip straightens.
The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
CONSULT THE LOCAL DISTRIBUTOR OR MANUFACTURER FOR THE APPROPRIATE INTERFACE CABLES.
INDICATIONS
The catheter is indicated for multiple electrode electrophysiological mapping the cardiac structures of the heart, i.e. recording or stimulation only. The Biosense Webster
L
ASSO
®
Circular Mapping Catheter is designed to obtain electrograms
in the atrial region of the heart.
CONTRAINDICATIONS
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The Biosense Webster
L
ASSO
®
Circular Mapping Catheter has not been shown to be safe and effective for radio frequency (RF) ablation.
•
Use of the catheter may not be appropriate for use in patients with prosthetic valves. A relative contraindication for cardiac catheter procedures is active systemic infection.
•
The
transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
•
The retrograde
approach is contraindicated because of risk of entrapping the
L
ASSO
®
in the left ventricle or valvular apparatus. The
L
ASSO
®
is not recommended for use in the
ventricles.
WARNINGS
•
Cardiac catheterization procedures present the potential for significant x
-
ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic
effects, to both patients and laboratory staff due to the x
-
ray beam intensity and duration of the fluoroscopic imaging.
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Cardiac catheterization should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps taken to
minimize this exposure.
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Careful consideration must be given for the use of this catheter in pregnant women.
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Do not immerse the proximal handle or cable connector in fluids; electrical performance could be affected.
•
Do not expose the catheter to organic solvents such as alcohol.
•
Do not autoclave the catheter.
•
Do not introduce L
ASSO
®
Catheter tip folded into the
guiding sheath.
•
The L
ASSO
®
Deflectable Circular Mapping Catheter is recommended for use with the Biosense Webster
P
REFACE
®
Braided Guiding Sheath.
Note: Do not use the
L
ASSO
®
Deflectable Circular Mapping Catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25
mm in diameter.
PRECAUTIONS
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Store in a cool, dry, dark place.
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Do not attempt to operate the Biosense Webster
L
ASSO
®
Circular Mapping Catheter prior to completely reading and understanding these Instruct
ions for Use.
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Cardiac catheterization procedures should be performed by appropriately trained personnel in a fully equipped electrophysiology laboratory.
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Careful manipulation must be performed in order to avoid 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 resistance 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.
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The Biosense Webster
L
ASSO
®
Circular Mapping Catheter is intended for single patient use only.
•
Do not re
sterilize and reuse.
•
This device is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity
of the device and/or lead to device failure that in t
urn may result in patient injury, illness or death. Also, reprocessing or resterilization 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.
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
