Siemens ACUSON AcuNav 8F Gebrauchsanleitung

ACUSON AcuNav Ultrasound Catheter
The symbols on the label, catheter, connector, and Directions for Use are defined in
the ACUSON AcuNav Ultrasound Catheter User Manual.
CONVENTIONS
Convention Description
Catheter ACUSON AcuNav 8F diagnostic ultrasound catheter
ACUSON AcuNav 10F diagnostic ultrasound catheter
Connector SwiftLink catheter connector
DESCRIPTION
Each catheter is sterile, disposable, and licensed for single use only. The
ACUSON AcuNav ultrasound catheter distal end has an ultrasound transducer
providing 2-D imaging. A steering mechanism controls the image plane orientation
through four-way articulation of the tip.
The catheter is intended for intracardiac and intraluminal visualization of cardiac and
great vessel anatomy and physiology as well as visualization of other devices in the
heart.
Refer to your ultrasound system user documentation for information about catheter
and connector compatibility with your ultrasound system.
CONTRAINDICATIONS
WARNING: The catheter is not for use in coronary vessels or fetal tissue. Using
the catheter in coronary vessels or fetal tissue can cause patient injury.
Use of the catheter is 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 or abnormalities.
USE GUIDELINES
Caution: In the United States of America, federal law restricts this device for
sale or use by, or on the order of, a physician.
Use of the catheter is only by or under the supervision of physicians well trained in
cardiac catheterization. Preferably, physicians using the catheter have been trained
in the placement and use of intracardiac imaging devices and in the interpretation of
the resulting ultrasound images.
DIRECTIONS FOR USE
WARNING: Do not resterilize, reprocess, or reuse the catheter. Reusing the
catheter can damage the structural integrity of the catheter and can result in a
contaminated catheter. Use of a contaminated catheter can cause patient
infection. Use of a contaminated catheter can transmit infectious disease from
one patient to another. Use of a contaminated catheter can result in patient
illness or death.
WARNING: Completely read and understand the ACUSON AcuNav Ultrasound
Catheter User Manual and your ultrasound system user documentation before
you attempt to connect the catheter to any ultrasound system and operate the
catheter. Failure to completely read and understand the ACUSON AcuNav
Ultrasound Catheter User Manual and your ultrasound system user
documentation can result in patient injury.
The Directions for Use are intended as a review of catheter procedures. The
Directions for Use do not include essential background and instructional information
that is necessary for successful use of the catheter. Refer to the ACUSON AcuNav
Ultrasound Catheter User Manual and your ultrasound system user documentation
for complete catheter use directions.
Physicians interested in further training in the use of the catheter should contact
their catheter distributor for training opportunities.
Adverse Reactions
Adverse events related to cardiac catheterization have been documented. Adverse
events related to cardiac catheterization 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, arteriovenous (AV)
fistula, stroke, and death.
Interfering Substances or Devices
It is imperative that you are aware of the pacemaker or implantable cardioverter-
defibrillator (ICD) needs of the patient. If use of the catheter interferes with the
function of the patient's implantable device, immediately discontinue use of the
catheter.
10030119-ABS-001-12-12
Procedure Preparation
WARNING: Do not use the connector if the connector appears damaged in any
way. Using a damaged connector can result in patient or user injury. Contact
your connector distributor.
WARNING: Do not immerse the connector. Moisture trapped between the
connector and the catheter can damage the connector and/or the catheter,
causing possible patient or user injury or death. Do not use the connector if the
connector appears wet. Contact your connector distributor.
WARNING: Do not use the catheter if the packaging is open or damaged. Using
a catheter that has been stored in an open or damaged package can result in
patient or user injury. Contact your catheter distributor.
WARNING: Do not use the catheter if the catheter appears damaged in any
way. Using a damaged catheter can result in patient or user injury. Contact your
catheter distributor.
Before you begin the preparation procedures, power on the ultrasound system.
To prepare the catheter and connector for use in an ultrasound exam:
1. Inspect the connector for damage.
2. Inspect the sterile package and the catheter prior to use.
3. Using proper sterile technique, remove the catheter from the sterile package.
Place the catheter in a sterile working area.
4. Inspect the entire catheter for damage.
5. Rotate the steering knobs. The steering function should be smooth. The
catheter tip should flex in a corresponding direction up to 160°.
Note: If the catheter tip does not 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.
7. Connect the system connector to the ultrasound system.
8. Slip the sterile sheath over the catheter interconnect tab until the sheath is fully
seated on to the catheter handle.
9. Lift the lever on the connector. Slip the connector on to the catheter interconnect
tab until the connector is fully mated with the catheter handle. Push the lever
down, locking the catheter to the connector.
10. Carefully slip the sterile sheath over the connector. Cover enough of the
connector so the connector is out of the sterile field.
11. Verify that the imaging screen appears.
During the Procedure
WARNING: Do not use excessive force to advance or withdraw the catheter.
Using excessive force can result in patient injury or death. Ensure that the two
steering knobs are in the neutral position and the tension control knob is
released before advancing or withdrawing the catheter. If you encounter strong
resistance during catheter articulation, discontinue the procedure. Identify and
address the cause of the resistance before resuming the procedure. Withdraw
and redirect the catheter as needed.
Caution: Excessive bending or kinking of the catheter can damage internal
wires and/or distal tip articulating capabilities.
To conduct an ultrasound exam using the catheter:
1. Create a vascular access with a catheter introducer (hemostatic) large enough
to accommodate the catheter with heparinized saline.
2. Before advancing or withdrawing the catheter, ensure that the steering knobs
are in the neutral position and that the tension control knob is released.
3. Advance the catheter into the vasculature through the catheter introducer.
Fluoroscopy can aid in advancing the catheter into the heart.
4. When the catheter is inside the heart, use the steering knobs to direct the
ultrasound transducer to visualize the target cardiac anatomy.
Procedure Conclusion
WARNING: Regard the used catheter, introducer, and sheath as biohazardous,
infectious waste. Dispose of the used catheter, introducer, and sheath according
to local, state, and regional regulations for biohazardous waste. Observe local,
state, and regional regulations for the disposal of electrical and electronic
equipment. Wear appropriate protective gear while handling the used catheter,
introducer, and sheath. Failure to dispose of the used catheter properly can
result in harm to the environment and to anyone who comes in contact with the
used catheter.
WARNING: Do not resterilize, reprocess, or reuse the catheter. The catheter is
disposable and is licensed for single use only. Reusing the catheter can
damage the structural integrity of the catheter and can result in loss of proper
electrical and mechanical function. Use of a damaged catheter can result in
patient injury or death.
To end an ultrasound exam using the catheter:
1. Before you withdraw the catheter, ensure that the steering knobs are in the
neutral position and that the tension control knob is released.
2. Withdraw the catheter from the patient.
3. Dispose of the catheter, introducer, and sheath.
Disposing of the Packaging Materials
Local laws and regulations may require manufacturers to collect and dispose of
packaging materials at no cost to the customer. Contact your catheter or connector
distributor for information about packaging collection and disposal policies in your
region.
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