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Please read all information carefully.
Failure to properly follow the instructions may lead to serious surgical consequences, such as leakage
or disruption.
Important: This package insert is designed to provide instructions for use of the EchElon™ 45
Endoscopic linear cutter Reloads. It is not a reference to surgical techniques.
Indications
The EchElon 45 Endoscopic linear cutter – Straight, compact EchElon 45 Endoscopic linear cutter
– Straight, and long EchElon 45 Endoscopic linear cutter – Straight are intended for transection,
resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally
invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with
staple line or tissue buttressing materials. The instruments may also be used for transection and resection of
liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Contraindications
•
Do not use the instruments on ischemic or necrotic tissue.
•
Do not use the instruments on the aorta.
•
Do not use any linear cutter on major vessels without making provision for proximal and
distal control.
•
Tissue thickness should be carefully evaluated before firing any stapler. Refer to the Reload Product
codes Table below for tissue compression requirement (closed staple height) for each staple size. If
tissue cannot comfortably compress to the closed staple height listed in the table, or easily compresses
to less than the closed staple height listed in the table, the tissue is contraindicated as it may be too
thick or too thin for the selected staple size.
•
These instruments are not intended for use when surgical stapling is contraindicated.
Device Description
The EchElon 45 Endoscopic linear cutter – Straight, compact EchElon 45 Endoscopic linear
cutter – Straight, and long EchElon 45 Endoscopic linear cutter – Straight are sterile, single patient
use instruments that deliver staples while simultaneously dividing tissue between rows. EchElon 45
instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The
instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments
have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. A
staple retaining cap on the reload protects the staple leg points during shipping and transportation
The instruments are shipped without a cartridge and must be loaded prior to use. Use only the indicated
cartridges in the EchElon 45 Endoscopic linear cutter instrument. EchElon 45 Endoscopic linear
cutter cartridges are interchangeable across all EchElon 45 Endoscopic linear cutter family instrument
codes. Do not use ECHELON 45 Endoscopic Linear Cutter family cartridges in an instrument other than
an EchElon 45 Endoscopic linear cutter family instrument.
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