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EN-16
TLAB
®
Transjugular Liver Biopsy System
Directions for Use
INDICATIONS FOR USE
For transjugular liver access biopsy.
CONTRAINDICATIONS
None Known.
Sound professional judgment should be used to determine if use of this product is inadvisable due to specific patient
characteristics, including, but not limited to: thrombosis of the internal jugular vein, untreated infections or reaction
to contrast medium. The clinician should evaluate the risks of potential complications of the procedure, including, but
not limited to: arteriovenous fistulas, puncture site hematoma, intraperitoneal hemorrhage, cardiac arrhythmias, and
puncture of other organs.
PRECAUTIONS
Directions for Use (
“
DFU
”
) assume clinical training in transjugular liver access biopsy procedures. This DFU is NOT
intended to define or suggest any medical or surgical technique. The clinician is responsible for proper procedural
technique and use of this product. Contact us and request technical assistance prior to using this product if you do not
completely understand this DFU. Confirm packaging integrity for sterility, product condition and expiration dating prior
to use. Contrast material, fluoroscopic and ultrasound visualization are required to ensure accurate placement.
Continuous cardiac monitoring is suggested as negotiating devices past the right atrium may cause cardiac
arrhythmias. Manipulation of radiopaque or other tips, reformation of devices or harsh handling may
adversely impact performance or result in damage including, but not limited to, device fragmentation or tip
detachment.
PRESENTATION
The TLAB
®
Patel Set
®
Transjugular Liver Biopsy System is presented in a Chevron Tyvek
®
Peel Pouch, which includes up
to five sterile pouches in a master pouch. The inner pouches include:
Содержание TLAB
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