Amplatzer Amulet Gebrauchsanweisung Seite 10

100105566_Amulet.book Page 3 Tuesday, May 20, 2014 1:05 PM
thrombus formation, transient ischemic attack, valvular regurgitation/insufficiency, vascular access
site injury, vessel trauma/injury.
Directions for Use
Materials recommended for use with the AMPLATZER™ Amulet™ Left Atrial
Appendage Occluder
• AMPLATZER™ Guidewire (9-GW-002)
• 35-cc syringe
• Delivery sheath with inner diameter appropriate for device size (see table T1)
Note: The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder is recommended for
use with the AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath
Note: Do not oversize or undersize the delivery sheath. Follow the recommended sizes
listed in table T1.
Procedure
1. Evaluate the patient using transesophageal echocardiography (TEE) to rule out the
presence of intracardiac thrombus (including left atrial appendage thrombus) and
presence of pericardial effusion.
2. Prepare the patient for a standard transcatheter procedure, including administration of
oral antiplatelet medication. Effective anticoagulation therapy should be maintained
during and after the procedure as determined by the physician. After a transseptal
puncture is performed, maintain a recommended activated clotting time (ACT) of at least
250 seconds until the procedure is complete.
3. Perform a transseptal puncture.
4. Gain access to the left atrium and place the AMPLATZER™ Guidewire into the left atrial
appendage. It may be helpful to place the guidewire in the left upper pulmonary vein first.
CAUTION: Use caution when advancing the guidewire.
5. Use angiography and echocardiography to measure the left atrial appendage, including
the depth of the left atrial appendage (shown as W in Table T2) and the maximum width
of the orifice (shown as U in Table T2). Image the left atrial appendage until it is clearly
visible. Identify and measure the left atrial appendage at the landing zone (defined as
about 10 mm-12 mm from the orifice) for the device lobe (shown as V in Table T2) to
determine the appropriate device size to occlude the left atrial appendage. Confirm the
orifice measurement U is less than the disc size of the selected device. See table T2 on
the foldout of the back cover to determine the appropriate device size to occlude the left
atrial appendage.
WARNING: Do not implant the device if the measurements of the left atrial appendage do
not fall within the sizing chart in table T2.
Note: Ensure the measurement system is appropriately calibrated.
6. Prepare the delivery sheath for use according to the manufacturer's instructions for use.
7. Prepare the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder and delivery
assembly for use:
- Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the
device or delivery assembly if the sterile barrier has been compromised.
- Gently open the sterile packaging and inspect the components for damage. Do not use
damaged or kinked components.
- Remove the delivery cable and device from packaging.
8. If desired, slide the delivery cable vise over the delivery cable. Tighten the delivery cable
vise onto the delivery cable.
9. Connect the hemostasis valve to the loader hub and turn the rotating luer to tighten.
10. Advance the device until the distal end screw is flush with the distal end of the loader.
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