Contraindications - Johnson & Johnson Biosense Webster SoundStar 3D M-5276-646A Mode D'emploi

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 Diagnostic
OUND TAR
Ultrasound Catheter (hereinafter S S
OUND TAR
Catheter) is a sterile, single-use, 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
®
the C XP System EP Navigation System
ARTO
Version 9.7 or greater. A steering mechanism
controls the image plane orientation by rotating both
®
the S S Catheter tip and the variable
OUND TAR
deflection.
®
The S S Catheter is validated for use only
OUND TAR
with GE ultrasound systems (Vivid-i** and Vivid-q**),
®
and the C XP EP Navigation System Version
ARTO
®
9.7 or greater (hereinafter C XP System). Use
ARTO
the appropriate SwiftLink* Catheter connector to
®
connect the S S Catheter to the ultrasound
OUND TAR
system. Use the Hypertronic Catheter connector to
®
connect the S S Catheter to the C
OUND TAR
XP V9.7 System.
®
For use of the S S Catheter in
OUND TAR
mapping procedures, an additional R
EF
®
with Q P External Reference Patch is
WIK ATCH
required for location reference position
purposes. Refer to the documentation provided
®
with the C XP V9.7 System.
ARTO
®
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 the C XP EP Navigation System
ARTO
®
Version 9.7 or greater, the S S 3D
OUND TAR
Catheter provides 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
V9.7 or greater Systems. The Directions for Use do
not include essential background, instructional, or
handling information related to the ultrasound
®
features of the S S Catheter, or when
OUND TAR
used with the ultrasound system only. For this
information refer to the AcuNav* Ultrasound
Catheter User Manual.
M-5276-646A
English
®
®
ARTO
®
S
TAR
®
XP
7
Release Date: 9/1/2009