Warnings:
•
Individual patient anatomy and physical conditions may require procedural variations.
•
Intended for Single Patient Use. DO NOT REUSE.
The Safety Excalibur Introducer is a single use device and must never be reused. Reuse carries with it the atten-
dant concern of cross-infection regardless of the cleaning or sterilization method. Resterilization of incompletely
cleaned devices may not be effective. Any device that has been contaminated by blood must not be reused or
resterilized.
•
After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical prac-
tice and applicable local, state and federal laws and regulations.
•
Do not reinsert needle while the sheath is in the vessel.
•
Do not alter this device
•
Do not attempt to override or defeat the locking mechanism.
•
If resistance is encountered In peeling the sheath, do not force the peeling action of the sheath or its withdrawal,
make procedural corrections, then continue.
Cautions:
•
Carefully read and follow all instructions.
•
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
•
Only qualified healthcare practitioners should insert, manipulate and remove these devices.
Precautions:
•
Follow Universal Precautions when inserting, removing and discarding this device.
I. Prior to beginning placement procedure, do the following:
•
Examine package carefully before opening to confirm its integrity and that the expiration date has not passed. The
device is supplied in a sterile package and is non-pyrogenic. Do not use if package is damaged, opened or the expi-
ration date has passed. Sterilized by ethylene oxide. Do not Resterilize.
•
Inspect kit for inclusion of all components.
II. To avert device damage and / or patient injury during placement:
•
To avoid blood vessel damage, do not allow the introducer sheath to remain indwelling in the blood vessel without
the internal support of a catheter or introducer needle.
•
Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).
Possible Complications:
• Air Embolism
• Bleeding
• Brachial Plexus Injury
• Endocarditis
• Hematoma Formation
• Intolerance Reaction to Implanted Device
• Laceration of Vessels or Viscus
• Perforation of Vessels or Viscus
• Risks Normally Associated with Local and General
Anesthesia, Surgery and Post-Operative Recovery
• Sepsis / Infection
• Vessel Damage
Instructions For Use:
1.
Perform Venipuncture
Warning: Do not alter this device
•
Remove the needle guard.
•
Hold the Safety Excalibur Introducer by the needle hub with a thumb and
fingers on opposite sides. The needle bevel and push-off tabs should be in
the UP position.
•
Anchor the skin with gentle skin traction. Insert the needle into the skin and
vein at an appropriate angle. Vein entry is confirmed with blood flashback
into the flash chamber. If necessary, slightly advance the Safety Excalibur
Introducer and needle together to assure full catheter entry into the vein.
•
Holding the needle stationary, advance the Safety Excalibur introducer
sheath into the vessel by pushing forward on the push-off tab.
2.
Withdraw the Safety Excalibur Introducer Needle
•
Support the Safety Excalibur Introducer sheath to avoid displacement.
•
Apply slight pressure on the vessel above the insertion site to minimize
blood flow.
•
Release the tourniquet.
•
Withdraw the needle from the Safety Excalibur Introducer sheath. As it is
withdrawn the safety blunter extends beyond the tip of the needle. An
audible "click" can be heard indicating that the safety blunter has been
activated.
Warning: Do not attempt to override or defeat the locking mechanism.
•
Dispose of the Safety Excalibur Introducer needle in an appropriate sharps
container.
3.
Insert and Advance the Catheter
•
Insert catheter, per catheter manufacturer’s instructions, into Safety
Excalibur Introducer sheath.
•
Advance the catheter slowly. When the catheter tip has advanced at least
10 cm, the sheath may be removed.
4.
Retract and Remove the Safety Excalibur Introducer Sheath
•
Stabilize the catheter position by applying pressure to the vein distal to the
Safety Excalibur Introducer sheath.
•
Withdraw the Safety Excalibur Introducer sheath from the vein and away
from the site.
•
Split the Safety Excalibur Introducer sheath and peel it away from the
catheter.
•
The peel-away sheath should withdraw freely from the body. Warning: If
resistance is encountered In peeling the sheath, do not force the peeling
action of the sheath or its withdrawal, make procedural corrections, then
continue.
5.
Complete Catheter Insertion per catheter manufacturer’s instructions
•
Refer to catheter Instructions for Use for insertion and dressing procedure.
