Adverse Reactions; Procedure Preparation - 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.
English
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**)
®
•
Documentation for the C XP V9.7
ARTO
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 S S Catheter with the
OUND TAR
relevant ultrasound system. The tissue mimicking
material (TMM) temperature is displayed in
accordance with IEC 60601-2-37 requirements.
Ultrasound System TMM (Max Temp)
Vivid-i** 41.8°C
Vivid-q** 41.8°C
INTERFERING SUBSTANCES OR
DEVICES
It is imperative that you are aware of the
pacemaker needs of the patient. If use of the
®
S S Catheter interferes with the function
OUND TAR
of the patient's pacemaker, immediately
®
discontinue use of the S S Catheter
OUND TAR

PROCEDURE PREPARATION

Before you begin the preparation procedures, power
®
on the ultrasound system and the C XP V9.7
ARTO
®
System. To prepare the S S Catheter and
OUND TAR
SwiftLink* connector for use in an ultrasound exam:
1. Inspect the sterile package prior to catheter
use.
Warning against possible patient injury!
®
Do not use the S S Catheter if the
OUND TAR
packaging is open or damaged. In this case,
contact your local Biosense Webster
representative.
®
Using a S S Catheter that has been
OUND TAR
stored in an open or damaged package can
result in patient injury.
2. Using proper sterile technique, remove the
®
S S Catheter from the sterile
OUND TAR
®
package. Place the S S Catheter
OUND TAR
in a sterile working area.
®
3. Inspect the entire S S Catheter for
OUND TAR
damage.
4. Inspect the extension cable and the
® ®
R S with Q P External
EF TAR WIK ATCH
Reference Patch to ensure that the sterility
of the products or packaging have not been
compromised.
Warning against possible patient injury!
®
Do not use the S S Catheter if it is
OUND TAR
damaged. In this case, contact your local
Biosense Webster representative.
®
Using a damaged S S Catheter can
OUND TAR
result in patient injury.
5. Rotate the steering knobs. The steering
function should be smooth. The catheter tip
should flex in a corresponding direction.
®
Note: If the S S Catheter tip does not
OUND TAR
return to the neutral position after you release the
steering knobs, ensure that the tension control
knob is completely released. Release the tension
by rotating the tension control knob completely in a
counterclockwise direction.
6. Position the steering knobs in the neutral
position by aligning the marks on the
steering knobs to the marks on the housing.
8 M-5276-646A
Release Date: 9/1/2009