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Medtronic
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SIGADAPTSTND
Instructions for Use
3 pgs263.89 Kb0
User’s Manual
41 pgs1.87 Mb0

Medtronic SIGADAPTSTND User’s Manual

User Manual
™
Signia
Stapling System
en
User Manual
™
Signia
Stapling System
PT00032755
Table of Contents
1. System Overview.....................................................................................................................................1
3. Cleaning and Sterilization........................................................................................................33
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 and Endo GIA™ single-use reloads with Tri-Staple™ Technology .
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 handle.
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.
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 and electronic sensors. It is provided non-sterile and must be cleaned and sterilized prior to each use.
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System Overview
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.
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™
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System Overview
stapler is compatible with Endo GIA™ single-use reloads and Endo GIA™ single-use reloads with Tri-Staple™ Technology.
Indications for Use
The Signia™ stapler, when used with Endo GIA™ single-use reloads and Endo GIA™ single­use reloads with Tri-Staple™ Technology, 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 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, has applications in abdominal, gynecologic, pediatric and thoracic 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 and Endo GIA™ single-use reloads with Tri-Staple™ Technology 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 or Endo GIA™ single-use reload with Tri-Staple™ Technology 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.
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System Overview
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 and Endo GIA™ single-use reloads with Tri-Staple™ Technology 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.
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.
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System Overview
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.
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.
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System Overview
System Indicators
A.
2
1
E.
D.
(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.
F.
B.
C.
GREEN LED INDICATOR INDICATES
OFF Stapling reload is not loaded or fully clamped
ON Stapling reload is fully clamped
BLINKING
(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.
The green LED / safety button is pressed; device is entering firing mode
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
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BATTERY INDICATORS INDICATES
GREEN
Functional, sufficient charge, available for use.
YELLOW
Functional, low battery indicator, available firings, available for use.
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.
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