Johnson & Johnson EC45A, Instructions Manual

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Indications
The ECHELON families of endoscopic linear cutters (articulating and 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 the aorta.
• Do not use the instruments on ischemic or necrotic tissue.
• 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 ECHELON Reload Product Codes chart
below for tissue compression requirement (closed staple height) for each staple size. If tissue cannot comfortably compress to
the closed staple height, or easily compresses to less than the closed staple height, 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 Flex mm and 60 mm Articulating Endoscopic Linear Cutters are sterile, single patient use instruments
that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line.
The ECHELON Flex instruments have a staple line that is approximately mm long and a cut line that is approximately
mm long. The ECHELON Flex 60 instruments have a staple line that is approximately 60 mm long and a cut line that is
approximately 7 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion
of the shaft to pivot to facilitate lateral access to the operative site.
The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the
staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from
being refired.
Caution: Do not load the instrument more than 1 times for a maximum of 1 firings per instrument. The use of the instrument with
staple line reinforcement material may reduce the number of firings.
ECHELON Flex Instrument Product Codes
Instrument Description Shaft
Code Length
EC45A
ECHELON Flex
Articulating Endoscopic Linear Cutter 340 mm
SC45A
ECHELON Flex
Compact Articulating Endoscopic Linear Cutter 280 mm
EC45AL
ECHELON Flex
Long Articulating Endoscopic Linear Cutter 440 mm
EC60A
ECHELON Flex 60
Articulating Endoscopic Linear Cutter 340 mm
SC60A
ECHELON Flex 60
Compact Articulating Endoscopic Linear Cutter 280 mm
LONG60A
ECHELON Flex 60
Long Articulating Endoscopic Linear Cutter 440 mm
ECHELON Reload Product Codes
Note: The ECHELON Flex instruments may only be used with the ECHELON reloads.
Reload Closed Staple Reload Number Staple
Code Staple Height Line Length Color of Staples Rows
ECR45W 1.0 mm 45 mm White 70 6
ECR45B 1.5 mm 45 mm Blue 70 6
ECR45D 1.8 mm 45 mm Gold 70 6
ECR45G 2.0 mm 45 mm Green 70 6
ECR60W 1.0 mm 60 mm White 88 6
ECR60B 1.5 mm 60 mm Blue 88 6
ECR60D 1.8 mm 60 mm Gold 88 6
ECR60G 2.0 mm 60 mm Green 88 6