Johnson & Johnson Biosense Webster SoundStar 3D M-5276-463E Mode D'emploi page 7

WARNING: This is a controlled proprietary and confidential document.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
®
S S 3D D
OUND TAR IAGNOSTIC
U C
LTRASOUND ATHETER
 Caution: Federal (USA) law restricts
this device for sale by or on the order of
a physician.
DESCRIPTION
®
The Biosense Webster S S 3D
OUND TAR
Diagnostic Ultrasound Catheter (hereinafter
®
S S Catheter) is a sterile, single-use,
OUND TAR
disposable imaging catheter. The distal end of the
catheter has an ultrasound transducer providing
2-D imaging and a 3-D location sensor providing
®
location information to compatible C
ARTO
Navigation Systems with ultrasound capability.
A steering mechanism controls the image plane
orientation by rotating both the S S
OUND TAR
Catheter tip and the variable deflection.
®
The S S Catheter is validated for use with
OUND TAR
Siemens ultrasound systems (Acuson Sequoia*
and Acuson Cypress*), and compatible C
ARTO
Navigation Systems with ultrasound capability. The
®
S S Catheter is also validated with
OUND TAR
Acuson X300* Ultrasound System and C
ARTO
V9.7 EP Navigation System.
Use the appropriate SwiftLink* Catheter connector
®
to connect the S S Catheter to the
OUND TAR
ultrasound system. Use the Hypertronic Catheter
®
connector to connect the S S Catheter to
OUND TAR
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the C System.
ARTO
®
For use of the S S Catheter in
OUND TAR
mapping procedures, an additional location
reference device is required for location
reference position purposes. Refer to the
documentation provided with the C
ARTO
System.
For ultrasound purposes, the S S
OUND TAR
Catheter is identical to the Siemens AcuNav* 10F
Catheter. Refer to the AcuNav* Ultrasound
Catheter User Manual supplied by Siemens
Ultrasound ICE option.
INDICATIONS AND USAGE
®
The Biosense Webster S S 3D
OUND TAR
Diagnostic Ultrasound Catheter and related
accessory devices are indicated for intra-cardiac
and intra-luminal visualization of cardiac and great
vessel anatomy and physiology as well as
visualization of other devices in the heart. When
®
used with compatible C EP Navigation
ARTO
®
Systems, the S S 3D Catheter provides
OUND TAR
location information.
CONTRAINDICATIONS
®
Use of the S S Catheter is
OUND TAR
contraindicated under conditions where the cardiac
catheterization process would cause unacceptable
risk to the patient. Contraindicated conditions
include, but are not limited to, cases where
vascular access is inadequate. Known
contraindicated conditions include: sepsis, major
coagulation abnormalities, presence of any
intracardiac thrombus, presence of class IV angina
or heart failure, deep vein thrombosis, and
significant peripheral vascular disease. The
®
S S Catheter is not for fetal or pediatric
OUND TAR
use or for use in coronary vessels.
USE GUIDELINES
®
Use of the S S Catheter is only by or
OUND TAR
under the supervision of physicians well trained in
cardiac catheterization. Preferably, physicians
®
using the S S Catheter have been trained
OUND TAR
in the placement and use of intracardiac imaging
devices and in the interpretation of the resulting
ultrasound images. Physicians must be
appropriately trained and familiar with the
techniques for cardiac mapping procedures. All
mapping procedures must be performed in a fully
equipped electrophysiology (EP) laboratory.
DIRECTIONS FOR USE
These Directions for Use relate only to the safe and
®
effective use of the S S Catheter in
OUND TAR
conjunction with Biosense Webster C
ARTO
Systems with ultrasound capability. The Directions
for Use do not include essential background,
instructional, or handling information related to the
®
ultrasound features of the S S Catheter,
OUND TAR
or when used with the ultrasound system only. For
M-5276-463E
English
EP
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EP
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XP
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Release Date: 3/4/2010