Ethicon ECHELON FLEX Manual de usuario

In-Servicing Guide

ECHELON FLEX™ 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

Loading the device

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

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.

4. Snap the reload securely in place.

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.

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

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

Opening and closing the jaws

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.

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.

Four ways to articulate

1. Against the body wall

3. Against a grasper

2. Against tissue in the body

4. Hand assisted

Articulation

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.

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.

3. Pull back the red iring trigger lock. 4. Pull the exposed trigger to ire (motor will be audible).

Note: Alternatively, 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. Similarly, if the iring sequence is interrupted, the user may pulse the

iring trigger to continue the transection. It is recommended that the pulsing technique not be

initiated until after the knife blade indicator has moved into the closed bottom channel and is

no longer visible to minimize potential of inadvertent lockout.

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

home position.

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.

Opening the jaws

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.

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.

Reloading the device

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

2. Prior to reloading the stapler, hold the instrument in a vertical position with anvil and

cartridge jaw completely submerged in sterile solution. Swish vigorously to remove any

loose formed staples.

3. Wipe the inside and outside surfaces of the anvil and cartridge jaws to clean any unused

staples from the instrument.

4. Follow the same steps outlined earlier in the Loading the device section.

Stapler lockout

Under certain circumstances, the stapler will lock out. These include instances when no cartridge or an incorrect or used cartridge is present. At any time, if the knife reverse

switch does not return the knife to the home position and the jaws will not open:

1. Reverse: Slide the knife reverse switch forward.

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.

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.

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.

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

2. Move the lever FORWARD AND BACKWARD until it can no longer be moved. The

forward and backward movement of the lever may require multiple cycles and

should be completed until the knife blade is conirmed to be in the home position.

Note: After the manual override is used, the device becomes disabled for any

subsequent irings.

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.

2. The battery pack should be returned to a battery collection point. It must not be

disposed of in the hospital waste

1. Disconnect the 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.

Recycling of batteries is obligatory in the European Union. If the battery pack requires decontamination prior to disposal, follow your hospital‘s protocol or below instructions.*