Ethicon ECHELON FLEX Powered Plus Bedienungsanleitung

In-Servicing Guide

ECHELON FLEX™ Powered and

Powered Plus Staplers

Nomenclature

Battery Pack

Anvil Release Button

Knife Reverse Switch

Manual Override

Articulation Joint Shaft

Articulation Fin and Rotating Knob

Reload Alignment Slot

Firing Trigger

Closing Trigger

Red Firing Trigger Lock

Knife Blade Indicator

Anvil Jaw

Reload/Cartridge Jaw

1. Install the battery pack. An audible click will be heard when the

battery pack is fully inserted. It can be inserted in either orientation;

there is no up or down.

Note: Tissue thickness should be carefully evaluated prior to using

the instrument. Refer to the Reload Product Codes Chart for proper

reload selection.

5. Remove the staple-retaining cap by lifting it straight up and discard.

Loading the Device

3. Ensure that the staple retaining cap is present. Insert the reload

by sliding it against the bottom of the reload jaw until the stapler

alignment tab stops in the reload alignment slot of the jaw.

6. Observe the surface of the new reload to ensure no colored drivers

are visible and that the reload lies lat in the jaw channel.

4. Snap the reload securely in place.

2. Verify that the reload size matches the instrument size to be used

(e.g., use 60mm reload with 60mm stapler).

1. Close the jaws of the instrument by squeezing the closing trigger

until a click is heard. The audible click indicates that the closing

trigger and the jaws are locked.

2. To open the jaws, squeeze the closing trigger, and then

simultaneously push the anvil release button on the side of the

device. Maintain pressure on the anvil release button and slowly

release the closing trigger.

Opening and Closing the Jaws Articulation

Four Ways to Articulate

Ensure that the jaws are in the open position.

1. Pull back and hold the articulation in to activate the articulation joint.

2. Apply lateral pressure to the jaws to articulate the device.

3. Release articulation in to lock jaws into articulated position.

4. Clamp, staple, cut, return, release.

1. Against the body wall 3. Against a grasper

2. Against tissue in the body 4. Hand assisted

Firing the Device

1. Ensure that the tissue lies lat and is positioned properly between the

jaws and that no obstructions (e.g., clips, stents) are within the jaws.

Any “bunching” of tissue along the reload may result in an incomplete

staple line.

2. Fully close the closing trigger until it clicks (audible click will occur).

Note: Holding the jaws in place for 15 seconds after closing and prior

to iring may result in better compression and staple formation.

3. Pull back the red iring trigger lock.

4. Pull the exposed trigger to ire (motor will be audible).

Note: Alternately, for enhanced tissue compression when using the

ECHELON FLEX™ Powered Plus Stapler, the user may pulse the iring

trigger throughout the iring cycle until the transection is completed.

5. When the motor stops, release the iring trigger to automatically return

the knife to the home position.

Opening the Jaws

1. Ensure the knife is in the home position by doing a visual check

on the underside of the reload jaw. The jaws will not open if the knife

is not in the home position.

2. Squeeze the closing trigger, and then simultaneously push the anvil

release button on the side of the device. Maintain pressure on the

anvil release button and slowly release the closing trigger.

Stapler Lockout

1. Reverse: Slide the knife reverse switch forward.

2. Battery: Remove and re-install the battery to check that it is securely

installed and that the device has power.

3. Reverse: See Step 1.

4. Override: If the knife does not return, use the manual override (remove

the access panel labeled “Manual Override” on the top of the handle).

Note: After the manual override is used, the device becomes

nonfunctional.

Under certain circumstances the stapler will lockout. These include

instances when no cartridge or an incorrect or used cartridge are

present. At any time, if the knife reverse switch does not return the knife

to the home position and the jaws will not open:

Manual Override System

1. 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.

2. Apply force to move the lever forward and backward until it can no

longer be moved.

ONLY to be used if the reverse switch does not return the knife blade.

Reloading the Device

1. Push upward (toward the anvil) to unsnap the reload from the reload jaw.

2. Prior to reloading the instrument, hold the instrument in a vertical position,

with anvil and reload jaw completely submerged in sterile solution. Swish

vigorously and then wipe the inside and outside surfaces to clean any

unused staples from the instrument.

3. Follow the same steps outlined earlier in the “Loading the Device” section.

Battery Pack Disposal

IMPORTANT: Do NOT incinerate/autoclave battery pack in

the hospital.

• Per the manufacturer, the batteries are not to be exposed to

temperatures above 100 degrees Celsius.

• The batteries are not reusable and do not need to be sterilized.

• Do not use Ethylene Oxide (EtO) process for battery pack.

*NOTE: In the event that the battery pack needs to be

decontaminated before disposal, follow this process between

Steps 1 and 2:

• Use a soft bristle brush to clean the battery pack surface with

a neutral pH detergent or neutral pH enzymatic detergent

(e.g., Simple Green D Pro 3,† 10% bleach, 70% isopropyl alcohol),

prepared according to the manufacturer’s instructions.

• Thoroughly scrub areas that contain crevices.

• Thoroughly wipe o detergent with lukewarm tap water (DO NOT

SUBMERGE IN WATER OR DETERGENTS).

• Visually inspect to ensure the debris is removed. Repeat cleaning

if necessary to obtain a visually clean battery pack.

†Simple Green D Pro 3 is a registered trademark of Sunshine Makers, Inc.

2. Discard pack in the normal medical waste stream.

1. Disconnect the battery pack.*

Because of the built-in battery drain, it is safe to discard the battery

pack in the normal medical waste stream. If your local regulations

require lithium batteries to be recycled, the battery pack must irst be

decontaminated according to the instructions below.

For complete product details, see Instructions for Use.

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