Covidien Signia Stapling System, User Manual

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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.
System Overview