Ethicon Echelon Flex PCEE45A Manual Del Usuario página 8

Indications
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters
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 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, 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.
Undesirable Side Effects/Residual Risks
Undesirable side effects and risks associated with powered surgical stapling include the potential for bleeding, tissue injury, introduction of
non-sterile surfaces or pathogen transfer, inflammatory or unintended tissue reaction, property or environmental damage, electrical shock, and
foreign body magnetic resonance incompatibility. Also, unintended harm, extended surgery, or altered surgical approach may result from staple
line failures, inability to cut, or damaged devices.
Device Description
The ECHELON FLEX™ Powered Plus 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™ 45 Powered Plus
instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The ECHELON FLEX™ 60
Powered Plus instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 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 packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for
disposing of the battery pack. Refer to the Battery Pack Disposal section.
The instruments are packaged 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 or improperly installed reload from being
refired or an instrument from being fired without a reload.
Caution: Do not load the instrument more than 12 times for a maximum of 12 firings per instrument. The use of the instrument with staple line
reinforcement material may reduce the number of firings.
Instrument Product Codes Table
Instrument
Code Description
PCEE45A ECHELON FLEX 45 mm Powered Plus Compact Articulating Endoscopic Linear Cutter
PSEE45A ECHELON FLEX 45 mm Powered Plus Articulating Endoscopic Linear Cutters
PLEE45A ECHELON FLEX 45 mm Powered Plus Long Articulating Endoscopic Linear Cutter
PCEE60A ECHELON FLEX 60 mm Powered Plus Compact Articulating Endoscopic Linear Cutter
PSEE60A ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter
PLEE60A ECHELON FLEX 60 mm Powered Plus Long Articulating Endoscopic Linear Cutter
Reload Product Codes Table
WARNING: The ECHELON FLEX™ 45 mm Powered Plus instruments may only be used with the ECHELON ENDOPATH 45 mm reloads.
The ECHELON FLEX™ 60 mm Powered Plus instruments may only be used with the ECHELON ENDOPATH 60 mm reloads.
Reload Open
Code Staple Height
GST45W 2.6 mm
GST45B 3.6 mm
GST45D 3.8 mm
GST45G 4.1 mm
GST45T 4.2 mm
GST60W 2.6 mm
GST60B 3.6 mm
GST60D 3.8 mm
GST60G 4.1 mm
GST60T 4.2 mm
Closed Staple
Staple Height Line Length
1.0 mm 45 mm
1.5 mm 45 mm
1.8 mm 45 mm
2.0 mm 45 mm
2.3 mm 45 mm
1.0 mm 60 mm
1.5 mm 60 mm
1.8 mm 60 mm
2.0 mm 60 mm
2.3 mm 60 mm
1
and reloads
Shaft
Length
280 mm
340 mm
440 mm
280 mm
340 mm
440 mm
Reload Number
Color of Staples
White 70
Blue 70
Gold 70
Green 70
Black 70
White 88
Blue 88
Gold 88
Green 88
Black 88
are intended for
Staple
Rows
6
6
6
6
6
6
6
6
6
6