Adverse Reactions - Webster SoundStar 3D Instrucciones De Uso

WARNING: This is a controlled proprietary and confidential document.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
English
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 (Sequoia*, Cypress*, or X300*)
®

Documentation for the C System
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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
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relevant ultrasound system. The tissue mimicking
material (TMM) temperature is displayed in
accordance with IEC 60601-2-37 requirements.
Ultrasound System TMM (Max Temp)
Sequoia* 42.1°C
Cypress* 42.1°C
X300* 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
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of the patient's pacemaker, immediately
®
discontinue use of the S S Catheter.
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COMPATIBLE C SYSTEMS
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®

C XP (version 9 and higher)
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®

C 3
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PROCEDURE PREPARATION
Before you begin the preparation procedures,
power on the ultrasound system and the C
®
System. To prepare the S S Catheter and
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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
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packaging is open or damaged. In this case,
contact your local Biosense Webster
representative.
®
Using a S S Catheter that has been
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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
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®
package. Place the S S Catheter
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in a sterile working area.
®
3. Inspect the entire S S Catheter for
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damage.
4. Inspect the extension cable to ensure that
the sterility of the products or packaging
have not been compromised. Inspect the
location reference device for damage.
 Warning against possible patient injury!
®
Do not use the S S Catheter if it is
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damaged. In this case, contact your local
Biosense Webster representative.
®
Using a damaged S S Catheter can
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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
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return to the neutral position after you release the
steering knobs, ensure that the tension control
8 M-5276-463E
®
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Release Date: 3/4/2010