English - CooperSurgical CTI-1012P Instrucciones De Uso

Carter-Thomason
CTXL-P • Carter-Thomason
DEVICE DESCRIPTION
The Carter-Thomason II Port Closure System is
available in four kit configurations consisting of
the following components:
CTI-1012P:
• One (1) Suture Passer
• One (1) 10/12 mm Suture Guide
CTI-1015P:
• One (1) Suture Passer
• One (1) 10/12 mm Suture Guide
• One (1) 15 mm Suture Guide
CAUTION
• U.S. Federal law restricts this device to sale by or on the order of a physician.
• Dispose of in accordance with all applicable Federal, State, and local Medical / Hazardous
waste practices.
INDICATION FOR USE
The Suture Passer is intended to pass suture through soft tissues of the body during endoscopic/
laparoscopic surgery.
It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
PRECAUTIONS
• A surgeon should not begin clinical use of the Suture Passer without a full understanding
of the directions for use.
• The Suture Passer is not recommended for use in surgical procedures where the position of the
needle tip cannot be clearly determined.
• The grasping fingers of the instrument must be closed completely in order to form a needle point
to pass suture through tissue. Release button on the Suture Passer to draw suture completely
into mechanism.
• The Suture Passer needle point can injure internal tissues and/or any personnel in contact with the
pointed end of the instrument. The Suture Passer needle point should be protected at all times with
the protective cap when the instrument is not in use.
CARTER-THOMASON II SUTURE PASSER INSTRUCTIONS FOR USE
The Suture Passer has two operating positions: Fingers Open and Fingers Closed (see illustrations).
1. To suture, open the finger grasping mechanism by pressing on the plunger
on the handle of the guide. We recommend the use of Vicryl Size 0 braided
sutures (CSI approved suture material via validations).
2. Place suture in the finger mechanism.
3. Close the grasping fingers by releasing the plunger.
4. Pass the needle point with the suture through tissue by pushing
distally on the handle.
5. Open the grasping fingers to drop the suture.
6. Close the grasping fingers and remove the Suture Passer.
7. With the grasping fingers in the closed position, reinsert the Suture Passer
in proximity to the first entry point.
8. Open the grasping fingers to retrieve suture by pressing on the plunger
on the passer handle.
9. Close the grasping fingers by releasing the plunger.
10. Remove the Suture Passer with the suture in place.
CTI-1012P, CTI-1015P, CTI-15P
Instructions for Use (English)
II Port Closure System
®
II Port Closure System XL
®
CTI-15P
• One (1) Suture Passer
• One (1) 15 mm Suture Guide
CTXL-P:
• One (1) XL Suture Passer
• One (1) 10/12 mm XL Suture Guide
• One (1) 15 mm XL Suture Guide
The Suture Passer is a sterile, single-case use, hand-
held suture grasping device that is designed to pass
suture through soft tissue.
The Suture Guide is a single use device that
is designed to work with the Suture Passer for
placement of the suture through soft tissue.
3
Grasping Fingers
Open
Grasping Fingers
Closed