Johnson & Johnson ECHELON FLEX + Manual De Instrucciones página 5

Indications
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads 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 the 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 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 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 Chart
Instrument
Code Description
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 Chart
WARNING: The ECHELON FLEX 60 mm Powered Plus instruments may only be used with the ECHELON 60 mm reloads.
Open Closed Staple
Reload Code Staple Height Staple Height Line Length
GST60W 2.6 mm 1.0 mm 60 mm
GST60B 3.6 mm 1.5 mm 60 mm
GST60D 3.8 mm 1.8 mm 60 mm
GST60G 4.1 mm 2.0 mm 60 mm
GST60T 4.2 mm 2.3 mm 60 mm
Clinical Section
Examples of procedures in which linear cutters and staplers may be used include:
General Gynecologic
• Anastomoses • Vaginal Hysterectomy
• Partial Gastroplasty
• Appendectomy
Shaft
Length
340 mm
440 mm
Reload Number Staple
Color of Staples Rows
White 88 6
Blue 88 6
Gold 88 6
Green 88 6
Black 88 6
Urologic Thoracic
• Nephrectomy • Lung Resection and Biopsy
• Cystectomy • Pulmonary Wedge Resection
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lllustrations and Nomenclature (Illustration 1)
1. Closing Trigger 8. Knife Reverse Switch
2. Red Firing Trigger Lock 9. Rotating Knob
3. Firing Trigger 10. Articulation Fins
4. Anvil Release Button 11. Reload (Cartridge)
5. Battery Pack 12. Reload Gripping Surface
6. Battery Pack Release Tab 13. Reload Alignment Tab
7. Manual Override Access Panel 14. Reload Alignment Slot
Instructions for Use
Prior to Using Instrument
1 Verify that the reload size matches the instrument size to be used (e.g. use an ECHELON 60 mm Reload with Gripping Surface
Technology reload with an ECHELON FLEX 60 Powered Plus instrument).
Become familiar with the articulating action of the instrument by pulling on the fins of the rotating knob with the index finger and
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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 fins of the rotating knob to release the lock; the jaws will return automatically.
3 Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions).
Preparing the Instrument for Use
4 Using sterile technique, remove the instrument, battery pack, and reload from their respective packages. To avoid damage, do not flip the
instrument, battery pack, or reload into the sterile field.
5 Install the battery pack. The battery pack must be installed prior to use. Insert the battery pack by lining up the release tabs on the battery
pack with the slots on the rear of the instrument. It can be inserted in either orientation; there is no up or down (Illustration 3). Ensure
battery pack is fully inserted into the device. An audible click will be heard when the battery pack is fully inserted.
Note: The instrument must be used within 12 hours of inserting the battery pack. Refer to the Battery Pack Disposal section for battery
pack disposal instructions.
6 Prior to inserting the reload, ensure the instrument is in the open position (Illustration 1).
7 Examine the reload for the presence of a staple retaining cap. If the retaining cap is not in place, discard the reload.
Caution: Tissue thickness should be carefully evaluated prior to using the instrument. Refer to the Reload Product Codes Chart for
proper reload selection.
Caution: Selection of the appropriate staple cartridge should be based upon the combined thicknesses of both the tissue and the staple line
reinforcement material. The use of staple line reinforcement material with the instrument may require an increased force to close and may
reduce the number of times the device may be fired. When using staple line reinforcement material, the instructions of the manufacturer of
the material should be followed.
8 Insert the reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment slot.
Snap the reload securely in place. Remove the staple retaining cap and discard (Illustration 4). The instrument is now loaded and ready for
use.
Caution: After removing the staple retaining cap, observe the surface of the new reload. The reload must be replaced with another reload
if any colored drivers are visible. (If colored drivers are visible, the reload may not contain staples.)
Using the Instrument
9 Close the jaws of the instrument by squeezing the closing trigger until it locks in place (Illustration 5). An audible click indicates that
the closing trigger and the jaws are locked. When the jaws of the instrument are closed, the red firing trigger lock and firing trigger are
exposed.
Note: Do not pull the red firing trigger lock or firing trigger at this time. The instrument may be partially or completely fired and will need
to be reloaded before using on tissue.
10 Visually inspect the stapler to ensure proper cartridge seating. Introduce the instrument into the body cavity through a trocar of the
appropriate size or through an incision (Illustration 6). When using a trocar, the instrument jaws must be visible past the trocar sleeve
before opening the jaws.
Caution: For insertion and removal of articulating instruments, the jaws of the instrument must be straight, parallel to the shaft of the
instrument. Failure to have the instrument jaws in the straight position will result in difficult insertion or withdrawal of the instrument and
may result in damage to the instrument.
Caution: When placing the instrument through the trocar or incision, avoid inadvertently pulling the red firing trigger lock and the firing
trigger. The instrument may be partially or completely fired and will need to be reloaded before using on tissue. If the instrument is
partially fired, remove the instrument and slide the knife reverse switch forward to return the knife to home position (Illustration 7). To
open the jaws, squeeze the closing trigger, then simultaneously press the anvil release switch on either side of the instrument (Illustration
8a). While pressure is still on the anvil release switch, slowly release the closing trigger (Illustration 8b). Remove the reload and insert a
new one (see Reloading the Instrument). If the instrument is fired completely, the knife will return to home position automatically. Remove
the instrument and insert a new reload (see Reloading the Instrument).
Note: At any time, if the knife reverse switch does not return the knife to home position and the jaws will not open:
a. First, ensure the battery pack is securely installed and the instrument has power (Illustration 9); then, try the knife reverse
switch again (Illustration 7).
b. If the knife still does not return, use the manual override. After the manual override system is used, the instrument is disabled
and cannot be used for any subsequent firings. To use the manual override, remove the access panel labeled "Manual Override" on
the top of the instrument handle. The manual override lever will be exposed. Move the lever forward and backward until it can no
longer be moved (Illustration 10). The knife will now be in the home position. This can be verified by viewing the position of the
knife blade indicator on the underside of the cartridge jaw (Illustration 11). Discard the instrument.
15. Staple Retaining Cap
16. Anvil Jaw
17. Cartridge Jaw
18. Staple Line
19. Cut Line
20. Proximal Black Line
21. Knife Blade Indicator
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