English
M-5276-214E
5
L
ASSO
®
2515 Variable Circular Mapping Catheter
Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.
WARNING:
•
To reduce the risk of entrapping cardiac structures in the mapping-electrode portion of the catheter, place the L
ASSO
®
2515 Variable Circular
Mapping Catheter by torquing (or rotating) the shaft in a clockwise motion only.
•
When not in regions intended for mapping, manipulate the catheter with the loop in the fully expanded (i.e. 25 mm diameter) position to further
reduce the risk of entrapping cardiac structures.
•
STERILE. Sterilized with ethylene oxide gas.
•
For one single use only.
•
Do not autoclave.
•
Do not use if the package is open or damaged.
CATHETER DESCRIPTION
The Biosense Webster L
ASSO
®
2515 Variable Circular Mapping Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart. It is deployed in the
right or left atrium through an 8F guiding sheath, similar to Biosense Webster’s
P
REFACE
®
Guiding Sheaths. This deflectable catheter consists of a 4F circular spine on its distal tip,
with platinum electrodes that can be used for stimulation and recording.
The L
ASSO
®
2515 Variable Circular Mapping Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-
fit veins with different sizes,
ranging from 25mm to 15mm diameter (± 15%).
With the catheter pointing away from you, rotate the handle to the right to reduce the diameter of the loop. Rotating the han
dle to the left increases the loop diameter (see Figure 1).
When the handle is fully rotated to
the right, the minimum 15mm diameter is attained.
Likewise, when the handle is rotated fully to the left, the maximum diameter of 25mm is attained. Pushing forward on the cath
eter thumbknob deflects the tip of the catheter. When
the thumbknob is pulled ba
ck, 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 of the cardiac structures of the heart,
i.e. recording or stimulation only. The L
ASSO
®
2515 Variable Circular Mapping Catheter is designed to obtain
electrograms in the atrial region of the heart.
CONTRAINDICATIONS
•
The L
ASSO
®
2515 Variable 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
®
2515 Variable Circular
Mapping Catheter in the left ventricle or valvular apparatus. The L
ASSO
®
2515 Variable Circular Mapping Catheter
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.
•
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.
•
Careful consideration must be given for the use of this catheter in pregnant women.
•
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.
•
To avoid potential damage to anatomical structures, do not attempt to pull the catheter, or withdraw it into the sheath, with
the loop in a contracted position. The loop should be
fully relaxed (handle grip rotated fully to the left) to minimize tension applied to the Nitinol structure.
•
Do not introduce the L
ASSO
®
2515 Variable Circular Mapping Catheter tip folded into the guiding sheath.
Catheter Tip
Connector
F
IGURE
1
– L
ASSO
®
2515
Variable Circular Mapping
Catheter electrodes.
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
