INSTRUCTIONS
FOR USE
Signia™
Manual Retraction Tool
PT00048743
REMOVING THE STAPLING RELOAD
If the stapler fails to remove the reload from the tissue, the following procedures may be used to attempt to retract the knife and open the jaws of the stapling
reload.
WARNING: Depending upon the failure, the procedures described below may or may not be successful in retracting the knife and
opening the stapling reload. Professional experience should be used to assess patient status when deciding the best course of
action.
NOTE: The alternative opening procedures can be performed utilizing the existing power stapler in use or with a new power
stapler if a replacement power handle and sterile control shell are available. Insert a charged power handle into a sterile control
shell, following the Power Handle Insertion Steps section of the Signia™ stapling system’s user manual.
POWERED OPENING APPROACH
PRECAUTION: Care should be taken to support the adapter and clamped reload during disassembly to prevent distal tip movement
and/or tissue damage.
1. Stabilize the adapter and remove the stapling handle by pressing the QUICK RELEASE button on the top of the adapter while simultaneously pulling the
stapling handle off of it.
2. Reattach the existing stapling handle or a new stapling handle onto the adapter and connected reload. Upon connection to the adapter, the device will run
through a calibration process and recognize if a reload is attached. It will then attempt to reverse the knife blade, forcing the knife to retract and open the stapling
reload.
3. Once the stapling reload is disengaged from tissue, remove the power handle from the patient and inspect the staple line and surrounding tissue for
hemostasis and/or leakage.
POWER HANDLE REBOOT APPROACH
PRECAUTION: Rebooting the power handle during a firing or incomplete firing will stop the firing process.
1. To force a reboot, simultaneously press and hold both SAFETY buttons for up to 10 seconds. Release the buttons and the device will reboot.
NOTE: Upon reboot, the device will run through a calibration process and recognize if a reload is attached. It will then attempt to
reverse the knife blade, forcing the knife to retract and open the stapling reload.
2. Once the stapling reload is disengaged from tissue, remove the stapler from the patient and inspect the staple line and surrounding tissue for hemostasis and/
or leakage.
MANUAL OPENING PROCEDURE
Use the following manual retraction tool procedure if another power stapler is not available to perform the above powered opening approaches.
WARNING: The manual retraction tool is intended to be used as a back-up device for the Signia™ stapler should the stapler
experience a failure during operation. It can be used to complete a firing that has already been initiated, or to retract the knife
and open the jaws to remove a reload from tissue. It should NOT be used to initiate a new firing of a stapling reload.
WARNING: The manual retraction tool is provided non-sterile. Clean and sterilize before each use.
1. Remove the power stapling handle from the adapter by pressing the black QUICK RELEASE button on the adapter while pulling the handle off of it.
PRECAUTION: Care should be taken to support the adapter and clamped reload during disassembly to prevent distal tip movement
and or tissue damage.
2. To control the firing, insert the manual retraction tool into the center hole marked with the number 1 on the proximal end of the adapter.
3. To continue firing the stapling reload, turn the manual adapter tool counterclockwise.
4. To retract the knife and open the jaws of the stapling reload, turn the manual adapter tool clockwise and in the direction of the arrow indicator.
PRECAUTION: Retracting the knife and opening a fully fired stapling reload using the manual retraction tool may take up to 8
minutes. The user should consider this when deciding on the best course of action in the event of a failure of the power stapling
handle.
NOTE: If the reload is articulated, insert the manual retraction tool into the hole marked with the number 2 on the proximal
end of the adapter. Center the reload, and remove the instrument from the patient. Refer to the instructions in the Disassembly
section of the Signia™ stapling system’s user manual.
NOTE: When the stapling reload is orientated so the lower clamp cover is up and the anvil is down, turning the manual adapter
tool counterclockwise will articulate the reload to the right. Turning it clockwise will articulate the reload to the left.
WARNING: If a device malfunction occurs during a procedure or the manual retraction tool is used, do not attempt to reuse the
power stapler, power handle, adapter, or the stapling reload. Contact Covidien for return instructions.
PRECAUTION: After firing and removing the Signia™ stapler from the patient, always inspect the staple line and the surrounding site
for hemostasis and/or leakage. Minor bleeding or leakage may be controlled by using electrocautery or sutures.
CLEANING, DISINFECTION, AND STERILIZATION
NOTE: The manual retraction tool is made from metal and plastic.
Warnings
Detergents and solutions should have a pH between neutral and 10.8.
Sterilization temperature should not exceed 279 °F (137 °C).
The manual retraction tool is supplied non-sterile. Prior to use it must be cleaned and sterilized.
Before Use
Clean and sterilize the manual retraction tool prior to each use following the instructions provided.
After Use
The manual retraction tool should be cleaned thoroughly after every use to remove all traces of blood and debris. Reprocess as soon as possible following use. If
reprocessing cannot be performed immediately, cover the instrument with a moist towel.
MANUAL CLEANING
NOTE: The Signia™ manual retraction tool should be cleaned in the open position; with external and internal handles in either an
open V shape (45° angle relative to the shaft) or T shape (90° angle relative to the shaft).
1. Wipe down the device with a lint-free cloth soaked in 32-40 °C pH-neutral detergent solution diluted per manufacturer’s instructions.
2. Under 32-40 °C running water, scrub all reachable surfaces with an 11.9 mm soft nylon bristle brush for 1-2 minutes to remove surgical debris. Pay particular
attention to the indentations on the interior of the handles.
3a. For enzymatic detergents (validated with Steris Prolystica™* 2x Concentrate): immerse the device in a 32-40 °C enzymatic bath diluted as specified by the
manufacturer’s Instructions for Use and soak for 5-10 minutes.
3b. For alkaline detergents (non-enzymatic pH greater than 9.5 but less than 10.8) (validated with neodisher MediClean forte™*): immerse the device in a
32-40°C alkaline bath diluted as specified by the manufacturer’s Instructions for Use and soak for 5-10 minutes.
4. Manually agitate the device in the bath for at least 1 minute.
5. Repeat step 2.
6. Rinse under warm running tap water (32-40 °C) for at least one minute.
7. Perform a final rinse under purified water for a minimum of one minute.
8. Dry with a clean, soft, lint-free cloth
9. Inspect the device. If not visibly clean, repeat the above steps.
AUTOMATIC CLEANING
NOTE: The Signia™ manual retraction tool should be cleaned in the open position; with external and internal handles in either an
open V shape (45° angle relative to the shaft) or T shape (90° angle relative to the shaft).
NOTE: The Signia™ manual retraction tool should be placed in the washer-disinfector lying flat to assist drainage and in such a
manner to avoid contact with other devices (damage may occur as a result of movement during wash cycle).
1. Wipe down the manual retraction tool with a lint-free cloth soaked in 32-40 °C pH-neutral detergent solution diluted per manufacturer’s instructions.
2. Under 32-40 °C running water, scrub all reachable surfaces with an 11.9 mm soft nylon bristle brush for 1-2 minutes to remove surgical debris. Pay particular
attention to the indentations on the interior of the handles.
3. Rinse under running tap water (32-40 °C) for at least 1 minute.
4. Perform the automatic cleaning cycle, following the parameters in the table below:
A
B
C
D
Box Size: 4 x 10
Overall Size: 8.5 x 11
Folds to: 8.5 x 3.667
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques.
DESCRIPTION
The Signia™ manual retraction tool is a reusable instrument accessory for the Signia™ stapler, which is composed of the Signia™ power handle, Signia™ power
shell and Signia™ adapters. The Signia™ manual retraction tool is designed for use with Signia™ adapters to provide manual operational control of the stapling
reload and articulation controls in the event of a malfunction during operation. It is intended to be used only to complete a firing that has been initiated, to
retract the knife, and open the jaws and to de-articulate a stapling reload. It should not be used to initiate a new firing of the stapling reload. It is provided
non-sterile and must be sterilized before use.
For system configuration information and Instructions for Use, see the Signia™ stapling system’s user manual. Refer to each system component’s Instructions for
Use for detailed product descriptions and associated indications, instructions, contraindications, warnings, and precautions.
COMPATIBILITY
The manual retraction tool issued with the Signia™ adapter which is part of the Signia™ Stapler. Refer to the Signia™ stapling system’s user manual for
compatible single-use stapling reloads, loading units and cartridges including curved-tip reloads, radial reloads and reinforced reloads.
INDICATIONS FOR USE
The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with
compatible single-use staple reloads, reinforced reloads, loading units and cartridges has applications in abdominal, gynecological, pediatric, and thoracic
surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary
structures and for transection and resection of pancreas.
The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with
compatible curved tip single use reloads can be used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with
compatible single use radial reloads has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection
and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and
resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
CONTRAINDICATIONS
1. The manual retraction tool is contraindicated for initiating a new firing with a stapling reload.
2. Refer to the Instructions for Use provided with the selected stapling reloads for specific indications, contraindications, warnings, and precautions.
3. Refer to the Instructions for Use provided in the user’s manuals for the stapling system for specific indications, contraindications, warnings, and precautions.
SCHEMATIC VIEW
A) MANUAL RETRACTION TOOL
B) PROXIMAL END OF ADAPTER
C) CENTER TRI-LOBE STAPLING DIRECTIONAL CONTROL
D) RIGHT TRI-LOBE ROTATIONAL CONTROL
INSTRUCTIONS FOR USE
These instructions are not intended as a reference to surgical techniques.
WARNINGS AND PRECAUTIONS
1. The Signia™ stapler and manual retraction tool is to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and
use of surgical devices. Covidien™ single
‑
use reloads are intended for use in a sterile operating room environment in surgical procedures where surgical stapling
is indicated.
2. The manual retraction tool can only be used as a back-up means for operating the adapter controls. Should a malfunction occur in either the stapling reload or
the adapter, the stapling reload may not respond to inputs from the tool.
3. Inspect the manual retraction tool before use to ensure functionality.
4. Retracting the knife and opening a fully fired stapling reload using the manual retraction tool may take up to 8 minutes. The user should consider this when
deciding on the best course of action in the event of a failure of the stapler.
5. The manual retraction tool is provided non-sterile. Clean and sterilize before each use.
6. Use only the sterilization method that is recommended and qualified for the manual retraction tool as described in this document. Do not use hydrogen
peroxide gas plasma technology (such as Sterrad™* systems) or gamma sterilization to sterilize the tool.
7. After firing and removal of the instrument, always inspect the staple line and the surrounding site for hemostasis and/or leakage. Minor bleeding or leakage
may be controlled by electrocautery or sutures.
8. When dividing major vascular structures, be sure to adhere to the basic surgical principles of proximal and distal control.
9. Failure to completely fire the stapling reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/
or leakage.
TROUBLESHOOTING
Prior to using the manual retraction tool, review these troubleshooting scenarios related to firing of the reload.
The stapler is designed to stop firing a stapling reload if any of the following events occur:
• The DOWN / FIRE button is released and the UP / OPEN button is pressed during the firing process.
• The stapler senses a firing load that is in excess of the mechanical design limit of the stapling reload.
• The stapling reload completes firing.
If the stapler stops while firing a stapling reload, the following should be assessed:
1. Release the DOWN / FIRE button, and any other button or toggle that may be pressed.
2. Inspect the stapling reload for an obstruction, excessively thick tissue, or for completion of firing.
3. If continued firing is desired, attempt to complete the firing by pressing and holding the DOWN / FIRE button until firing is finished.
If the stapler is unable to complete the firing of the stapling reload:
1. Press the UP / OPEN button. The device will retract the knife to the fully clamped position, but the jaws will remain clamped on the tissue. Press up and hold
the UP / OPEN button to open the jaws of the instrument.
PRECAUTION: When dividing major vascular structures, adhere to the basic surgical principles of proximal and distal control.
2. If successful in removing the stapling reload from the tissue, refer to the user manual for the Signia™ stapling system to remove the stapling reload. If
unsuccessful, refer to the Removing the Stapling Reload section below.
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