Signia Stapling System User Manual

System Overview

1. System Overview Description Signia™ Stapling System The Signia™ stapler is an intelligent surgical stapler that provides push-button powered maneuverability and delivery of compatible stapling reloads. The Signia™ stapling system is the combination of the Signia™ stapler and system accessories. The Signia™ stapler is composed of the Signia™ power handle, Signia™ power shell, and Signia™ adapters. The system accessories include a reusable insertion guide, a manual retraction tool, a single-bay charger, and a four-bay smart charger. The Signia™ stapler is compatible with Endo GIA™ single‑use reloads, Endo GIA™ single‑use reloads with Tri‑Staple™ Technology, Tri‑Staple™ 2.0 single‑use reloads, and Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges.

Power Handle The Signia™ power handle is a non-sterile reusable, batterypowered stapling handle that includes microprocessors, electronics, motors, a OLED display screen, and a rechargeable lithium-ion battery −all within a sealed packet.

Power Shell The Signia™ power shell is a single‑use, sterile shell that covers the non-sterile Signia™ power handle to create an aseptic barrier, control interface, and universal adapter connector. It also provides a communications interface for Tri‑Staple™ 2.0 single‑use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single-use cartridges indicated for use with the Signia™ stapler.

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System Overview

Linear Adapters The Signia™ linear adapters are non-sterile reusable instruments that attach to the stapling handle to enable functionality of compatible stapling reloads. Included are motor mating connectors, electronic sensors, and communications interfaces for Tri‑Staple™ 2.0 single‑use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single-use cartridges indicated for use with the Signia™ stapler. It is provided non-sterile and must be cleaned and sterilized prior to each use.

Signia™ Stapler Accessories Descriptions Stapler Reusable Insertion Guide The Signia™ reusable insertion guide is used to help maintain the sterility of the power shell during insertion of a non-sterile Signia™ power handle. It is provided non-sterile and must be cleaned and sterilized prior to each use.

Manual Retraction Tool The Signia™ manual retraction tool is a reusable, handheld device that can be used to operate the adapter controls in the event of a malfunction during operation. The tool can be used to complete a firing, retract the knife and open the jaws, and/or articulate a stapling reload. It is provided non-sterile and must be cleaned and sterilized before use.

Single-Bay Charger The Signia™ single-bay charger is designed for use as an accessory to the Signia™ stapler and is used for charging the Li-ion batteries within the power handle. The charger will monitor the state of charge of a charging battery and report its status using color LEDs.

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System Overview

Four-Bay Smart Charger The Signia™ four-bay smart charger is designed for use as an accessory with the Signia™ stapler, which includes four power handle charging bays and a touch-screen LCD display screen. Its purpose is to charge the Li-ion batteries within the power handle. The touchscreen LCD is used to investigate the Signia™ power handle’s charge status.

Compatibility The Signia™ stapler is composed of the Signia™ power handle, Signia™ power shell and Signia™ adapters. Compatible accessories include a manual retraction tool, reusable insertion guide, a single-bay battery charger and four-bay smart charger. The Signia™ stapler is compatible with Endo GIA™ single‑use reloads, Endo GIA™ single‑use reloads with Tri‑Staple™ Technology, Tri‑Staple™ 2.0 single‑use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges.

Indications for Use The Signia™ stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ singleuse reloads with Tri‑Staple™ Technology, Tri‑Staple™ 2.0 single-use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single-use 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 the pancreas. The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads or Tri‑Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue. The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads with Tri‑Staple™ Technology, 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 the pancreas. The Signia™ stapler, when used with Endo GIA™ single use reinforced reloads with Tri‑Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri‑Staple™ 2.0 single use reinforced reloads preloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic

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System Overview

surgery for resection, transection of tissue 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 the pancreas.

Contraindications 1. Refer to the Instructions for Use provided with the compatible Endo GIA™ single‑use reloads, Endo GIA™ single‑use reloads with Tri‑Staple™ Technology, Tri‑Staple™ 2.0 single‑use reloads, and Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges for specific indications, contraindications, warnings, and precautions. 2. Tissue thickness should be carefully evaluated before firing any stapler. Refer to the Instructions for Use provided with the selected Endo GIA™ single-use reload, Endo GIA™ single-use reload with Tri‑Staple™ Technology, Tri‑Staple™ 2.0 single-use reload or Signia™ loading unit with Tri‑Staple™ 2.0 single-use cartridge for the specific contraindications regarding compressed tissue thickness for the selected reload. 3. Do not use the Signia™ stapler where adequacy of hemostasis cannot be verified visually after applications. 4. Do not use any linear cutter on major vessels without making provisions for proximal and distal control. 5. Do not use the instrument on ischemic or necrotic tissue. 6. The Signia™ stapler should not be used on friable or delicate tissue where the closure of the device might be destructive. 7. When using curved-tip reloads with the Signia™ stapler, do not use on tissue or structures that cannot fit completely within the reload jaws proximal to the transitional angle of the curved tip. 8. The Signia™ power shell is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE. 9. Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri‑Staple™ Technology, Tri‑Staple™ 2.0 single-use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single-use cartridges are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

Precautions and Warnings System-Specific Precautions and Warnings Precautions 1. This document is designed to assist in using this product. It is not a reference to surgical techniques. 2. Do not use the stapler if the packaging or device components appear damaged.

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System Overview

3. Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. Prior to performing any endoscopic procedures, consult the medical literature relative to techniques, complications, and hazards. 4. The stapler and associated components are 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. 5. A thorough understanding of the principles and practices of electrical equipment is essential to avoid shock and other hazards to the operators and/or the device accessories. Ensure that electrical isolation and outlet grounding are not compromised. 6. The stapler is a precise instrument. Care should be taken to avoid dropping. Handling or cleaning the power handle improperly, or sterilizing it, may shorten device life and/or lead to device failure. 7. The power handle is provided non-sterile. DO NOT STERILIZE. 8. The adapters are provided non-sterile. Clean and sterilize before each use. 9. The reusable insertion guide is supplied non-sterile. Clean and sterilize before each use. 10. The manual retraction tool is provided non-sterile. Clean and sterilize before each use. 11. Do not hold or carry the stapler by the distal end of the adapter or by the stapling reload. Warnings 12. The power shell is provided STERILE and is intended for use in a SINGLE procedure only. 13. The stapler does not directly sense tissue thickness. Select the stapling reload with an indicated tissue range that is appropriate for the target tissue. Overly thick or thin tissue may result in unacceptable staple formation. 14. After firing staples and removing 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. 15. When dividing major vascular structures, be sure to adhere to the basic surgical principles of proximal and distal control. 16. 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.

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System Overview

Component-Specific Warning and Precautions Refer to component specific Instructions for Use for specific individual component warning and precautions.

Adverse Reactions Adverse reactions, adverse events and potential complications may include but are not limited to: • seroma/hematoma • bleeding/hemorrhage/anastomotic leak • fistula • infection, which may include intraabdominal abscesses/sepsis • ischemia • chronic pain • allergic reactions • inflammatory reaction • visceral adhesions • nerve entrapment • tissue erosion • small bowel perforation • potential for stricture • potential for delayed gastric emptying, and the need for future re-operation.

System Indicators A. B. C. 2

1

D. E.

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F.

System Overview

(1) LED INDICATOR During use, the stapler uses an LED light, housed within the safety button, to indicate fully clamped status, readiness to fire, and fire-enabled status.

GREEN LED INDICATOR

INDICATES

OFF

Stapling reload is not loaded or fully clamped

ON

Stapling reload is fully clamped

BLINKING

The green LED / safety button is pressed; device is entering firing mode

(2) OLED DISPLAY SCREEN INDICATORS Graphical display indicators provide additional device status and operative readiness for use in separate zones within the status border indicator frame.

OLED SYSTEM INDICATORS

INDICATES

A.

System status

B.

Power status

C.

Reload recognition status

D.

Power handle and power shell status

E.

Adapter status

F.

Reload status

BATTERY INDICATORS

INDICATES

GREEN Functional, sufficient charge, available for use.

YELLOW Functional, low battery indicator, available firings, available for use.

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System Overview

RED Non-Functional, insufficient battery charge, not available for use.

Low battery status will indicate when there is enough battery charge to complete firing two linear staple reloads or cartridges. An insufficient battery charge will not allow you to continue to fire stapling reloads. Component Status Indicators Component status indicators will display the device life numerically for the stapler when setting it up. When the setup completes, the stapler will indicate it is ready for use with an audible sequence of tones.

Table 10. Signia™ Stapler Set up Sequence (e.g., using a Tri‑Staple™ 2.0 purple 60 mm reload). 1

2

3

Power handle procedures remaining

Insert power handle into power shell using insertion guide indicator

Power handle, power shell status and attach an adapter indicator

4

5

6

Power handle power shell, adapter status and attach a stapling reload indicator

Perform stapling reload cycle test before use indicator

Ready for use stapler system status indicator

Operational Use Indicators The stapler measures force when clamping and firing staples and will prevent the force

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System Overview

from exceeding predetermined safety limits. As it enters three specially developed, predetermined force zones, the device will adjust and maintain its firing speed in each zone to optimize staple formation

Table 11: Signia™ Stapler Force Feedback Display - (e.g., using a Tri‑Staple™ 2.0 Purple 60 mm reload) 1

2

Force zone 1, speed setting normal

Higher force zone 2, speed setting medium 4

3

Highest force zone 3, speed setting to Excessive force indicator, firing stops slow When using compatible Tri‑Staple™ 2.0 single‑use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges, communications will be enabled and force feedback measurements will display. The handle LED light will illuminate green when fully clamped and flash when in fire mode.

Firing Process 1. Press DOWN to fire and begin firing the stapler, the reload recognition bar fills green indicating firing progress. 2. Complete the fire when the knife reaches end of the reload and the reload recognition bar is completely filled green. 3. Press UP to retract the knife, the reload status bar and system status changes to inactive status indicating the device is no longer fully ready for use. 4. Upon completion of firing, the device with notify the user with an audible completion tone.

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System Overview

NOTE The handle LED will flash green during fire mode and stay illuminated when firing is complete. The LED will turn off when the reload is opened.

In Table 12, Images (1-3) indicate Tri‑Staple™ 2.0 Purple 60 mm reload, images (4-6) indicate using an Endo GIA™ single‑use reload or Endo GIA™ single‑use reloads with Tri‑Staple™ Technology and images (7-9) indicate using a Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges.

Table 12: Signia™ Stapler Firing Progress Indicators (e.g., using a 60 mm reload). 1

2

3

4

5

6

7

8

9

Reload status indicators will display reload size and length when using compatible Tri‑Staple™ 2.0 single‑use reloads and Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges. Reload travel distance indicators will display when using compatible Endo GIA™ single‑use reloads and Endo GIA™ single‑use reloads with Tri‑Staple™ Technology.

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System Overview

When using Signia™ loading units with Tri‑Staple™ 2.0 single‑use cartridges, an additional indicator circle for the single‑use cartridge will display to indicate its functional status when in use. Additional Controls Indicators The Signia™ stapler’s power rotation controls are preset ON as ambidextrous, but can be configured for dedicated right- or left-handed use. Configuring rotation buttons can occur at any time once a Signia™ adapter is attached.

NOTE The configuration will clear once the power pack is returned to the charger. Disable/Re-Enable Rotation Button Controls

Disable/Re-Enable Rotation Button Controls 1. Disable or re-enable rotation controls by pressing and holding both rotation buttons on one side of the handle for three seconds. The screen will show deactivation or reactivate countdown and change to its active status (see Table 13). 2. Pressing a single disabled rotation control will display the current disabled and active status.

NOTE Positive audible tones will notify when settings have been changed.

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System Overview

Table 13: Signia™ Stapler Special Use Controls – Disabling and re-enabling the rotation button controls. 1 Deactivation Sequence

2

Current Status Re-activation Sequence

Manually Changing Firing Speeds When fully clamped on tissue and in fire mode, the rotation buttons are turned off and are mapped into speed selection controls. Based on the force measured, the device will program the appropriate speed selection and faster speeds will not be available. To adjust to slower speeds, use the following steps: 1. Double click either lower rotation button to enter a slower speed setting. There are only three speed settings (Standard, Medium and Slow).

NOTE At any time the device measures higher force than programmed for a speed setting, the device will override the speed setting and move to a slower speed to optimize stapling performance.

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System Overview

Trouble Shooting Indicators If faced with any of the following errors, document the error and replace the instrument.

Table 14: Signia™ Stapler Error Trouble Shooting Guide 1

2

3

Battery error indicator

Power handle error indicator 5

General error indicator

General reload error indicator

7

General adapter error indicator 8

Loading unit error

General cartridge error

4

Power shell error indicator

NOTE All fault conditions are notified with an audible fault tone

13

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System Overview

End-Of-Life Indicators If faced with any of the following End-of-Life conditions, document the issue and replace the componen.

Table 15: Signia™ Stapler End of Life Guide 1

2

3

End-of-life service indicator – audible fault tone notification 4

Used power shell attached indicator

End-of-life adapter indicator

5

6

Used stapling reload attached

Used stapling cartridge attached

Used multi-use loading unit, no cartridge attached

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Instructions for Use

2. Instructions for Use These instructions are not intended as a reference to surgical techniques.

SET UP Three Hours Before First Use 1. Each new power handle unit is shipped in the OFF mode. Turn it on by placing the base of power handle into a battery charging terminal from back to front until a secure connection is established. The device will turn on and begin initializing. 2. For its first activation, the power handle should charge for a minimum of three hours before clinical use. Charging NOTE Refer to individual power charger Instructions for Use for additional information on set up and use

PRECAUTION Ensure that the power handle is sufficiently charged before use.

1. Insert the power handle into the battery charger, placing it into the battery charger bay facing forward and rock the base of the handle onto the terminal from back to front until a secure connection is established. 2. The charging cycle will start automatically when the power handle is inserted correctly into the battery charger. Charging time will depend on the amount of charge remaining in the power handle. Full charging of an empty battery takes approximately three hours. 3. To remove the power handle from the battery charger, grasp the power handle and carefully rock from front to back while removing to release the secure connection. Assembling The Signia™ Stapler Before assembling the Signia™ stapler, refer to the power handle display set up support graphics for user-guided display feedback (Tables 10-15).

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Instructions for Use

PRECAUTION The power handle is non-sterile and CANNOT BE STERILIZED.

PRECAUTION The power handle must be inserted into a sterile power shell with a sterilized reusable insertion guide while maintaining aseptic transfer principles. Use caution not to contaminate the sterile shell during power handle insertion

PRECAUTION Ensure that the power handle is sufficiently charged before use. Refer to the single-bay and four-bay smart charger sections in this manual or their individual Instructions for Use.

PRECAUTION The reusable insertion guide is provided non-sterile. It must be cleaned and sterilized prior to each use.

Power Handle Insertion Steps Step 1 and 2

Step 3

Reusable Insertion Guide

Extended Remover handle

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Step 4

Instructions for Use

Step 5

Secure Clips

Display Screen Status

1. SCRUBBED PERSON: After aseptically removing the sterile power shell from the packaging, carefully open the shell by holding the back handle of the shell so the front handle is facing up and away from the back handle. 2. SCRUBBED PERSON: Align and fully seat a clean, sterilized reusable insertion guide onto the back handle of the open power shell to provide an aseptic transfer guide when inserting the power handle into the shell.

PRECAUTION Ensure that the reusable insertion guide is properly seated onto the power shell and all clips are covered before inserting a power handle device.

3. CIRCULATING PERSON: While maintaining aseptic transfer techniques, insert the power handle into the insertion guide and power shell. 4. CIRCULATING PERSON: After the power handle is fully seated in the power shell, carefully remove the reusable insertion guide using the extended remover handle 5. SCRUBBED PERSON: Taking care not to touch the power handle, close the front portion of the power shell until there is tactile confirmation the base of the shell is closed and the front clips are secured. Check all three clips to confirm the shell is fully closed and securely locked.

PRECAUTION Ensure that both front clips are secured before use.

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Instructions for Use

6. Confirm successful connection of the sterile control shell with the power handle and the functional status of the stapler on the display screen (see Table 10).

Attaching The Adapter

PRECAUTION Signia™ adapters are REUSABLE and provided non-sterile. CLEAN and STERILIZE before use. Consult the Instructions for Use for the selected adapter for additional information.

PRECAUTION Do not attach an adapter to the power shell prior to inserting a power handle.

PRECAUTION Do not attempt to load a stapling reload before the adapter has been attached to the stapler and calibration has been completed. Doing so may lead to improper calibration and/or device damage.

NOTE If a stapling reload is attached to the adapter before the adapter is attached to the stapler, the adapter will not calibrate for use.

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Instructions for Use

PRECAUTION If a stapling reload is attached to the adapter in a clamped or fired position before the adapter is attached to the stapling handle, the stapler will attempt to retract the knife blade and fully open the jaws. The stapler will not allow the stapling reload to fire until the reload is removed and the adapter completes its calibration.

1. Align the proximal end of the adapter with the quick release button facing up and in the same orientation as the stapling handle. 2. Simultaneously, press the two components together until the adapter is fully seated into the stapling handle and tactile feedback is registered. 3. Confirm secure attachment by pulling the adapter and power handle in opposite directions. The stapler will automatically begin to calibrate the adapter and the status indicator light on the display screen will illuminate as shown in Table 10.

Loading A Stapling Reload

WARNING Always select a reload with the appropriate staple size for the tissue thickness. Overly thick or thin tissue may result in unacceptable staple formation.

PRECAUTION Do not attempt to remove the shipping wedge until the reload is loaded onto the adapter.

IMPORTANT When using compatible stapling reloads, refer to the indications, contraindications, warnings, and precautions described in the associated Instructions for Use.

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