Johnson & Johnson Biosense Webster SOUNDSTAR 3D Gebrauchsanweisung Seite 8

English
SOUNDSTAR
U
LTRASOUND
Caution: Federal (USA) law restricts this device
for sale by or on the order of a physician.
DESCRIPTION
The BIOSENSE WEBSTER SOUNDSTAR
Ultrasound Catheter (hereinafter SOUNDSTAR
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 compatible CARTO™ EP Navigation
Systems with ultrasound capability. A steering mechanism
controls the image plane orientation by rotating both the
SOUNDSTAR
The SOUNDSTAR
GE ultrasound systems (Vivid i**, Vivid q** and Vivid iq**),
and the compatible CARTO™ EP Navigation Systems with
ultrasound capability. Use the appropriate SwiftLink*
Catheter connector to connect the SOUNDSTAR
to the ultrasound system. Use the Hypertronic Catheter
connector to connect the SOUNDSTAR
CARTO™ XP V9.7 and CARTO™ 3 Version 1.1 Systems
when working with Vivid i** or Vivid q**, and to the
CARTO™ 3 Version 4, when working with Vivid iq**. Contact
your BWI Representative to get the correct CARTO™
Version for your configuration confirmed.
For use of the SOUNDSTAR
procedures, an additional location reference device is
required for location reference position purposes. Refer
to the documentation provided with the CARTO™
System.
For ultrasound purposes, the SOUNDSTAR
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 SOUNDSTAR
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 compatible CARTO™ EP Navigation Systems, the
SOUNDSTAR
CONTRAINDICATIONS
Use of the SOUNDSTAR
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 SOUNDSTAR
not for fetal or pediatric use or for use in coronary vessels.
USE GUIDELINES
Use of the SOUNDSTAR
supervision of physicians well trained in cardiac
catheterization. Preferably, physicians using the
SOUNDSTAR
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 SOUNDSTAR
BIOSENSE WEBSTER CARTO™ Systems with ultrasound
capability. The Directions for Use do not include essential
background, instructional, or handling information related to the
ultrasound features of the SOUNDSTAR
with the ultrasound system only. For this information refer to the
AcuNav* Ultrasound Catheter User Manual.
Warning against possible patient injury!
Failure to completely read and understand the
following documents could result in patient injury:

AcuNav* Ultrasound Catheter User Manual

Documentation for the ultrasound system
(GE Vivid i** or Vivid q** or Vivid iq**)

Documentation for the CARTO™ System
ADVERSE REACTIONS
Adverse events related to cardiac catheterization have been
documented and include, but are not limited to: femoral
artery or vein injury, thrombosis, pseudoaneurysm, cardiac
perforation, air embolism, pulmonary embolism, myocardial
infarction, valve or structural cardiac damage, cardiac
tamponade, pneumothorax, hemothorax, and death.
TRANSDUCER SURFACE TEMPERATURE
The following table provides the maximum surface
temperature of the SOUNDSTAR
ultrasound system. The tissue mimicking material (TMM)
temperature is displayed in accordance with IEC 60601-2-37
requirements.
Ultrasound System
Vivid i**
Vivid q**
Vivid iq**
8
3D D
®
C
ATHETER
Catheter tip and the variable deflection.
®
Catheter is validated for use only with
®
3D Catheter provides location information.
®
Catheter is contraindicated under
®
Catheter is only by or under the
®
Catheter have been trained in the placement
®
Catheter in conjunction with
®
WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
IAGNOSTIC
Catheter to the
®
Catheter in mapping
®
Catheter, or when used
®
Catheter with the relevant
®
TMM (Max Temp)
41.8°C
41.8°C
40.8°C
3D Diagnostic
®
Catheter) is
®
Catheter
®
Catheter is
®
3D Diagnostic
®
Catheter is
®
M-5276-646G
Released Date: 6/1/2017