Bard Excalibur Operating instructions

Brand: Bard

Model: Excalibur

Type: Operating instructions

Bard Access Systems

Safety Introducer

with

PUNCTUR-GUARD

Technology

Instructions for Use

Description:

The Safety Excalibur Introducer consists of two separate components: (1) stainless steel introducer needle, and (2) peel apart

catheter sheath. The stainless steel introducer needle has a clear plastic flash chamber for visualization of blood during nee-

dle placement.

The Safety Excalibur Introducer is designed to reduce the risk of accidental needle stick injuries. The needle is

equipped with a self-activating anti-stick protection mechanism. This mechanism automatically activates after the needle is

removed from the patient, but prior to removal of the needle from the sheath hub.

The introducer gauge size and length are identified on the product packaging. The maximum catheter French size to be used

with the introducer is marked on the cannula hub.

Indications:

The Safety Excalibur Introducer is intended for access of peripheral veins for the placement of Peripherally Inserted Central

Catheters and Midline catheters.

Contraindications:

Refer to catheter instructions for use for contraindications to catheter placement.

An issued or revision date for these instructions is included for the user’s information. In the event two years

have elapsed between this date and product use, the user should contact Bard Access Systems to see if

additional product information is available.

Revised date: January 2007

*BARD and Excalibur are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.

PUNCTUR-GUARD

is a registered trademark of Bio-Plexus, Inc.

Covered by one or more ot the following U.S. Patents: 4,828,547; 5,009,642; 5,221,263; 5,951,520.

PK0714222 / 0701R

Bard Access Systems, Inc.

Salt Lake City, UT 84116 USA

1-801-595-0700

Ordering Information: 1-800-545-0890

Clinical Information: 1-800-443-3385

Stainless Steel Introducer Needle

with

PUNCTUR-GUARD

* Technology

Peel-Apart Catheter Sheath

Protective Sheath

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.

Bard Excalibur Operating instructions

Bard Excalibur Operating instructions

Bard Excalibur Operating instructions

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