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Illustrations and Nomenclature (Illustration 1)
1. Closing Trigger
2. Red Firing Trigger Lock
3. Firing Trigger
4. Anvil Release Buttons (on either side)
Anvil Release Buttons (on either side)
5. Battery Pack
6. Battery Pack Release Tab
7. Manual Override Access Panel
Instructions for Use
Prior to Using Instrument
Verify that the reload size matches the instrument size to be used (e.g. use an ENDOPATH ECHELON Vascular White Reload for
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Advanced Placement Tip, (35mm, 4 Row) with an ECHELON FLEX Powered Vascular Stapler instrument.
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions).
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Preparing the Instrument for Use
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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.
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
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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.
Prior to inserting the reload, ensure the instrument is in the open position (Illustration 1).
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Examine the reload for the presence of a staple retaining cap. If the retaining cap is not in place, discard the reload.
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Caution: Tissue thickness should be carefully evaluated prior to using the instrument. Refer to the Reload Product Code Chart for
proper reload selection.
WARNING: Loading the incorrect reload for the instrument size or model may result in transecting the tissue without stapling (e.g.
loading a 35 mm reload into a 45 mm instrument).
Insert the reload by sliding it against the bottom of the channel jaw until the reload alignment tab stops in the reload alignment slot. Snap
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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 blue-colored drivers are visible. (If blue-colored drivers are visible, the reload may not contain staples.)
Using the Instrument
Close the jaws of the instrument by squeezing the closing trigger until it locks in place (Illustration 5). An audible click indicates that
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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: Applying pressure to the articulation lever during closure may cause the device to articulate.
Note: Do not pull the red firing trigger lock or firing trigger at this time. Doing so could cause the instrument to be partially or completely
fired and the instrument will need to be reloaded before using on tissue.
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Visually inspect the stapler to ensure proper reload 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. Doing so could cause the instrument to be partially or completely fired and the instrument 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 button on either side
of the instrument (Illustration 8a). While pressure is still on the anvil release button, 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 (Illustration 11b or 11c) 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 (Illustration 11b or 11c), 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 in the knife lockout window (Illustration 11a). Discard the instrument and dispose of the battery pack.
Once in the cavity, squeeze the closing trigger, then simultaneously press the anvil release button on either side of the instrument
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(Illustration 8a). While pressure is still on the anvil release button, slowly release the closing trigger to reopen the jaws and return the
closing trigger to its original position (Illustration 8b).
If needed, rotate the jaws by pushing on the fins of the rotating knob. (Illustration 12). The shaft will rotate optimally when the jaws of the
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device are open.
To articulate the jaws inside the body cavity, turn the articulation lever in either direction (Illustration 2) until one of the three pre-
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determined angles is reached. The predetermined angles are equal increments up to 50º from the straight configuration. Articulating while
closed does not provide optimal feedback and control, and may result in instrument damage.
WARNING: Do not attempt to articulate by pressing the front of the jaws against the grounding surfaces as device damage or tissue
trauma may occur.
8. Knife Reverse Switch
9. Rotating Knob
10. Articulation Lever
11. Reload
12. Reload Alignment Tab
13. Reload Alignment Slot
14. Staple Retaining Cap
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15. Anvil Jaw
16. Channel Jaw
17. Staple Line Length
18. Cut Line
19. Knife Blade Window
20. Knife Lockout Window
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