Ethicon Endo-Surgery ECHELON FLEX 45 Mode D'emploi page 5

Indications
The ECHELON™ families of endoscopic linear cutters 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 Powered 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 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 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 specifi c 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
refi red or an instrument from being fi red without a reload.
Caution: Do not load the instrument more than 12 times for a maximum of 12 fi rings per instrument. The use of the instrument with staple line
reinforcement material may reduce the number of fi rings.
Instrument Product Codes Chart
Instrument Description
Code
PSE45A ECHELON FLEX 45 Powered Articulating Endoscopic Linear Cutter
PCE45A ECHELON FLEX 45 Powered Compact Articulating Endoscopic Linear Cutter
PLE45A ECHELON FLEX 45 Powered Long Articulating Endoscopic Linear Cutter
PSE60A ECHELON FLEX 60 Powered Articulating Endoscopic Linear Cutter
PCE60A ECHELON FLEX 60 Powered Compact Articulating Endoscopic Linear Cutter
PLE60A ECHELON FLEX 60 Powered Long Articulating Endoscopic Linear Cutter
Reload Product Codes Chart
WARNING: The ECHELON FLEX instruments may only be used with the ECHELON reloads.
Reload Closed Staple
Code Staple Height Line Length
ECR45M 0.75 mm 45 mm
ECR45W 1.0 mm 45 mm
ECR45B 1.5 mm 45 mm
ECR45D 1.8 mm 45 mm
ECR45G 2.0 mm 45 mm
ECR60M 0.75 mm 60 mm
ECR60W 1.0 mm 60 mm
ECR60B 1.5 mm 60 mm
ECR60D 1.8 mm 60 mm
ECR60G 2.0 mm 60 mm
A88091P00 AMP IFU_1_18_12.indd 8-9 A88091P00 AMP IFU_1_18_12.indd 8-9
Shaft
Length
340 mm
280 mm
440 mm
340 mm
280 mm
440 mm
Reload Number Staple
Color of Staples Rows
Gray 70 6
White 70 6
Blue 70 6
Gold 70 6
Green 70 6
Gray 88 6
White 88 6
Blue 88 6
Gold 88 6
Green 88 6
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MR Conditional
Non-clinical testing has demonstrated the implantable staple made of titanium (Ti3Al2.5V) alloy in the ECHELON 45 and 60 reloads is MR
Conditional. It can be scanned safely under the following conditions:
• Static magnetic fi eld of 3 Tesla.
• Spatial gradient fi eld of 720 Gauss/cm.
• Maximum whole body averaged specifi c absorption rate (SAR) of 2.7 W/kg for 15 minutes of scanning.
MRI Related Heating
In non-clinical testing, the implantable staple made of titanium (Ti3Al2.5V) alloy in the ECHELON 45 and 60 reloads produced a temperature
rise of less than 2°C at a maximum whole body averaged specific absorption rate (SAR) of 2.7 W/kg, as assessed by calorimetry for 15 minutes
of MR scanning in a (3-Tesla/128-MHz, Excite, Software HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR scanner.
Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the ECHELON 45
and 60 implantable staple. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) per staple extends approximately 3-mm relative to the size and
shape of the implantable staple.
Pulse Sequence T1-SE T1-SE
Signal Void Size (mm 2 ) 17-mm 2 5-mm
Plane Orientation Parallel Perpendicular
Clinical Section
Examples of procedures in which linear cutters and staplers may be used include:
General Gynecologic
• Anastomoses • Vaginal Hysterectomy
• Partial Gastroplasty
• Appendectomy
Illustrations and Nomenclature (Illustration 1)
1. Closing Trigger
2. Red Firing Trigger Lock
3. Firing Trigger
4. Anvil Release Button
5. Battery Pack
6. Battery Pack Release Tab
7. Manual Override Access Panel
8. Knife Reverse Switch
9. Rotating Knob
10. Articulation Fins
11. Reload (Cartridge)
12. Reload Gripping Surface
13. Reload Alignment Tab
14. Reload Alignment Slot
15. Staple Retaining Cap
16. Anvil Jaw
17. Cartridge Jaw
18. Staple Line
19. Cut Line
20. Proximal Black Line
21. Knife Blade Indicator
Instructions for Use
Prior to Using Instrument
Verify that the reload size matches the instrument size to be used (e.g. use an ECHELON 60 reload with an ECHELON 60 instrument).
1
Become familiar with the articulating action of the instrument by pulling on the fi ns of the rotating knob with the index fi nger and
2
articulating the jaws with the other hand (Illustration 2). As lateral pressure is applied in either direction, the jaws pivot to a maximum
angle of 45 degrees, at which point the pivoting force increases to signal the end of the articulating arc. Maintain the lateral pressure
while releasing the rotating knob to lock the angle of the shaft. After locking the jaws, release the lateral pressure. The jaws will also lock
at approximate 15 and 30 degrees by releasing the rotating knob before the end of the articulation arc. To return the jaws to the straight
position, pull on the fi ns of the rotating knob to release the lock; the jaws will return automatically.
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions).
3
GRE GRE
2 42-mm 2 24-mm 2
Parallel Perpendicular
Urologic Thoracic
• Prostatectomy • Lung Resection and Biopsy
• Nephrectomy • Pulmonary Wedge Resection
• Cystectomy
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