Abbott Amplatzer Trevisio 9-ATV10F45 사용 지침 - 페이지 2
{카테고리_이름} Abbott Amplatzer Trevisio 9-ATV10F45에 대한 사용 지침을 온라인으로 검색하거나 PDF를 다운로드하세요. Abbott Amplatzer Trevisio 9-ATV10F45 5 페이지. Intravascular delivery system
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Warnings
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to
resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
• Do not use this device if the sterile package is open or damaged.
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• The sheath is designed to be used with the loader. Do not attach a syringe directly to the sheath because the sizing is
incompatible and may result in ingress of air or excessive bleeding.
• Use the hemostasis valve to impede the backflow of blood during the implant procedure.
• Do not use a power injection syringe to inject contrast solution through the sheath.
• Remove the dilator and sheath from the patient slowly to prevent an ingress of air.
Precautions
• Store in a dry place.
• This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should
determine which patients are candidates for procedures that use this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs
before, during, and/or after the use of this delivery system.
• Use caution when advancing the dilator and sheath to avoid damaging tissue and vessels or interfering with previously
implanted medical devices.
• Use standard transcatheter techniques when using Amplatzer™ products.
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this delivery system may include, but are not limited
to:
• Air embolism
• Arrhythmia
• Arteriovenous fistulae
• Bleeding
• Brachial plexus injury
• Cardiac tamponade
• Death
• Dissection
• Endocarditis
• Hematoma
• Infection
Device Compatibility
The Amplatzer™ devices compatible with the Amplatzer™ Trevisio™ Intravascular Delivery System are identified in
Table 1.
CAUTION: No devices other than those listed in this table have been tested for use with the delivery system. Using
untested devices with the delivery system may result in technical failures and/or adverse events.
Table 1. Compatibility Chart for Amplatzer™ Trevisio™ Intravascular Delivery System and Amplatzer™ Devices
Amplatzer™ Septal (ASD) Occluder
Amplatzer™ Multi-fenestrated ASD
(Cribriform) Occluder
Amplatzer™ Muscular VSD Occluder
Amplatzer™ P.I. Muscular VSD Occluder
Amplatzer™ PFO Occluder
• Myocardial infarction
• Perforation
• Peripheral embolism
• Peripheral pulse loss
• Stroke
• Thrombosis
• Tissue trauma/damage
• Valve damage
• Vascular occlusion
• Vessel trauma/damage
Amplatzer™ Trevisio™ Intravascular Delivery System Sizes
6 Fr
7 Fr
4–10 mm 11–17 mm
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4–10 mm
12 mm
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2
8 Fr
9 Fr
18 mm
20–24 mm
26–30 mm 32-38 mm
19 mm
18 mm
25 mm
35 mm
30 mm
14 mm
18 mm
16 mm
16 mm
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18 mm
18 mm
35 mm
25 mm
10 Fr
12 Fr
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20 mm
22 mm
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24 mm
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