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Merit Medical HeartSpan STEERABLE SHEATH INTRODUCER Gebrauchsanweisung Seite 2

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Instructions For Use
Carefully read all instructions prior to use.
Observe all contraindications, warnings
and precautions noted in these directions.
Failure to do so may result in patient
complications. Merit Medical Systems,
Inc. relies on the physician to determine,
assess, and communicate to each patient
all foreseeable risks of the procedure.
For U.S.-California Only.
Proposition 65, a State of California voter initiative requires
the following notice:
WARNING: This product and its packaging have been
sterilized with ethylene oxide. This packaging may expose
you to ethylene oxide, a chemical known to the state
of California to cause cancer or birth defects or other
reproductive harm.
CAUTION:
• Federal (USA) law restricts this device to sale by or on
the order of a physician. This device should be used
only by physicians thoroughly trained in percutaneous
procedures.
• Do not alter this device in anyway.
• This device is supplied sterile and intended for one-time
use only. Do not use any unit if its package is opened or
damaged. Do not re-sterilize and/or reuse.
HOW SUPPLIED:
Sterile: Sterilized with ethylene oxide gas.
Non-pyrogenic.
Not made with natural rubber latex.
Contents:
One (1) Radiopaque Steerable Sheath
One (1) Radiopaque Dilator
One (1) Guide wire
DESCRIPTION
The HeartSpan Steerable Sheath Introducer set consists
of a dilator, guide wire, and steerable sheath, which are
designed for catheter introduction into the cardiac anatomy.
The steerable introducer contains a hemostasis valve to
minimize blood loss during catheter introduction and/or
exchange. A sideport with three-way stopcock is provided
for air or blood aspiration, fluid infusion, blood sampling,
and pressure monitoring. The introducer handle includes
a rotating knob to enable clockwise and counterclockwise
tip deflection ≥180°. The steerable introducer also
includes distal holes to facilitate aspiration and minimize
cavitation, a radiopaque tip marker to improve fluoroscopic
visualization, an atraumatic soft tip, and a lubricious coating
on the inner and outer surfaces. The dilator is designed
to conform to the inner diameter of the sheath, and has
a tapered tip.
INDICATIONS
The HeartSpan Steerable Sheath Introducer is indicated
for introduction of various cardiovascular catheters into
the heart, including the left side of the heart through the
interatrial septum.
CONTRAINDICATIONS
• Previous intra-atrial septal patch.
• Known or suspected atrial myxoma.
• Myocardial Infarctions within the last two weeks.
• Unstable angina.
• Recent Cerebral Vascular Accident (CVA).
• Patients who do not tolerate anticoagulation therapy.
• Patients with an active infection.
• Presence of atrial thrombus.
WARNINGS
• Contents are supplied STERILE using an ethylene oxide
403194001MLP_001_heart_span_steerable_IFU.indd 2
English
(EO) process. Do not use if the sterile barrier is damaged.
• For single patient use only. Do not reuse, reprocess, or
resterilize. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/
or lead to device failure, which in turn may result in
patient injury, illness, or death. Reuse, reprocessing or
resterilization may also create a risk of contamination
of the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission
of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness, or
death of the patient.
• The device should be used by physicians engaged in the
practice of specialized invasive cardiology techniques.
Use of the device should be restricted to those physicians
specifically trained in the approach to be used.
• When the sheath is left in the vessel, a continuous
heparinized infusion under pressure through the sheath
sideport is strongly recommended.
• Infusion through the sideport should only be done after
all air is removed from the unit.
• Do not use a power injector through the sideport
extension or 3-way stopcock.
• Dilators and catheters should be removed slowly from
the sheath. Rapid removal may damage the valve
components, resulting in blood flow through the valve, as
well as cause a vacuum which may allow air to enter the
sheath.
• Aspiration of the sideport is recommended when
withdrawing the catheter, probe, or dilator, to remove
any fibrin deposition which may have accumulated in or
on the tip of the sheath.
• Careful sheath manipulation must be performed in the
presence of an implantable cardiac device of any kind,
to minimize the potential to displace or dislodge lead
placement.
• Direct percutaneous insertion of the sheath requires the
use of the dilator to minimize the potential risk of vessel
injury due to a flared tip.
• Fluoroscopic monitoring of the location of the distal tip of
the sheath using the radiopaque marker, especially when
used in a transseptal approach, is recommended.
• Maintain continuous hemodynamic monitoring
throughout the procedure.
• Prior to removing the steerable introducer, reinsert the
guide wire through the introducer. Re-introduce the
dilator over the guide wire, straighten the steerable
introducer, then remove the dilator, guide wire, and
introducer as a unit.
• Maximum in vivo time: 7 hours
PRECAUTIONS
• Aspiration and flushing of the sheath, dilator, and
catheter should be performed frequently to help
minimize the potential for air embolism or thrombus
formation.
• Indwelling sheaths should be internally supported by a
catheter, electrode, or dilator.
• Never advance, torque, or withdraw the guide wire,
dilator, or sheath when resistance is met. Determine the
cause by fluoroscopy and take remedial action.
• Use only the sideport for injection or aspiration of the
sheath and sideport assembly. Assure that the stopcock
is in the closed position after flushing, to prevent back-
bleeding. Aspirate slowly.
• The following conditions require that special care be
taken when using this product involving the transseptal
approach.
» enlarged aortic root
» marked right atrial enlargement
» small left atrium
» marked distortion of the thoracic configuration (e.g.
kyphosis or scoliosis)
• Care should be taken to avoid excessive bending of the
sheath and/or dilator before and during use.
• Fluoroscopic procedures involve exposure to ionizing
radiation by the patient and staff. Precautions to
minimize exposure should be taken and protective
equipment should be used.
• Fluoroscopic guidance should be used when advancing
the HeartSpan Steerable Sheath Introducer and/or dilator.
When advancing the sheath and/or dilator across a valve,
a guide wire or pigtail should be used.
• The sheath, dilator, and guide wire are designed for single
use only. Reuse may expose the patient to communicable
disease and/or injury.
• Arrhythmias may occur during the use of any intracardiac
device. Careful monitoring and availability of emergency
equipment are mandatory.
• When using the HeartSpan Steerable Sheath Introducer
in the presence of radio frequency ablation, care must
be taken to assure all ablating elements are outside the
sheath.
• The French sizes specified on the product labeling
represent the inside and outside diameters of the
introducer sheath.
• Do not attempt to insert a catheter having a distal tip or
body size larger than the inside diameter indicated on the
product labeling.
• The HeartSpan Steerable Sheath Introducer is designed
to interlock only with the accompanying dilator. Misuse
may result in serious complications.
• Do not attempt to use a guide wire larger than the
maximum diameter specified on the package label.
• Before inserting the device into the patient, assemble the
steerable Introducer and dilator.
• Do not remove the dilator or catheter rapidly. Damage to
the sheath valve could occur.
• Do not deflect the device beyond 180° prior to Insertion
of an 8 mm tip electrode catheter.
• STORE IN A COOL, DARK, DRY PLACE.
POTENTIAL COMPLICATIONS
Potential complications that may occur during the use of
this device include, but are not limited to:
• air embolism
• arterial thromboembolism
• cardiac tamponade
• death
• infection
• interatrial septum dissection
• intimal tear
• hematoma
• perforation
• peri-interventional stroke
• pseudoaneurysm
• thrombus formation
Please consult the respective manufacturer's labeling for
adverse events associated with the use of cardiovascular
catheters.
HOW SUPPLIED
The HeartSpan device kit is supplied sterile within a chevron
pouch. The package contents are listed above.
PROCEDURAL CONSIDERATIONS
Carefully read the instructions before use of this device
to help reduce the potential risks associated with the
transseptal technique, such as air emboli or perforation
of the aorta or left atrium. Only those physicians who
are trained in transseptal procedures should use this
device. Fluoroscopy should be used to confirm positioning
throughout the procedure. Transseptal procedures should
be performed only in appropriately equipped and staffed
facilities. Lab capabilities should include, but are not
limited to:
» intracardiac pressure monitoring capabilities
» systemic pressure monitoring
» contrast media injection, and management of
untoward reactions to contrast media
» pericardiocentesis
» surgical backup
» anticoagulation therapy and monitoring
• Monitor vital signs throughout the procedure.
• Inspect all components before use.
• Use only a HeartSpan transseptal needle with a mating
stylette.
• Prior to inserting the device into the patient, assemble
the sheath and dilator, insert the HeartSpan needle into
the dilator, and check for excessive resistance as the tip
1/8/16 1:30 PM

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