Bard AirGuard Bedienungsanleitung

INSTRUCTIONS FOR USE

ACCESS SYSTEMS

DESCRIPTION

The AirGuard* Valved Introducer is designed to reduce blood

loss and the risk of air intake but is not a hemostasis valve.

• The valve will substantially reduce air intake when compared

to a non-valved introducer of the same size.

• The valve will substantially reduce the rate of blood ﬂ ow

when compared to a non-valved introducer of the same size,

but some blood loss through the valve may occur.

INTENDED USE

The AirGuard* Valved Introducer is indicated for use in the

percutaneous insertion of catheters in the venous system.

CONTRAINDICATIONS

Do Not Use the AirGuard* Valved Introducer in the arterial

system or as a hemostatic device.

WARNINGS

Intended for Single Use. DO NOT REUSE. Reuse and/or repackag-

ing may create a risk of patient or user infection, compromise the

structural integrity and/or essential material and design charac-

teristics of the device, which may lead to device failure, and/or

lead to injury, illness or death of the patient. Do not resterilize.

After use, this product may be a potential biohazard. Handle and

discard in accordance with accepted medical practice and all

applicable laws and regulations.

CAUTION: Federal (USA) law restricts this device to sale by or on

the order of a physician.

• Read instructions for use carefully before using this device.

• Sterilized by ethylene oxide.

• Sterile, non-pyrogenic unless package is damaged or opened.

PRECAUTIONS

The valve is not intended to create a complete two-way seal nor

is it intended for arterial use.

This introducer is not designed to prevent air embolism resulting

from a sudden venous pressure change caused by an action such

as coughing.

POSSIBLE COMPLICATIONS

The use of an indwelling central venous catheter provides an

important means of venous access for critically ill patients;

however, the potential exists for serious complications including

the following:

• Air Embolism

• Brachial Plexus Injury

• Exit Site Infection

• Hematoma

• Hemothorax

• Perforation of Vessels or Viscus

• Pneumothorax

• Venous Thrombosis

• Intra-Thoracic Hemorrhage

INSERTION TECHNIQUE

1. Remove the sheath/dilator assembly from the package,

remove sheath and dilator from the protective tube.

2. Insert the dilator through the valve and lock in place using

the rotating collar.

3. After percutaneous access has been achieved, and leaving

the guidewire in place, advance the introducer/dilator

assembly over the guidewire and into the vein.

4. Remove the dilator and guidewire together from the

introducer/dilator assembly by unlocking the rotating collar

and gently withdrawing the dilator from the sheath.

NOTE: Leaving the guidewire in place after removing the

dilator may cause the valve to leak.

5. Advance the catheter through the valve. To prevent kinking

the catheter, it may be necessary to advance in small steps by

grasping the catheter close to the sheath.

CAUTION: If placing the catheter with side holes, advance

catheter tip(s) quickly through valve to minimize risk of air

leakage through the catheter’s side holes.

6. After the catheter has been positioned, crack the sheath

handle in half.

7. Remove the sheath from the patient.

Rotating Collar

An issued or revision date for these instructions is included

for the user’s information. In the event 2 years have elapsed

between this date and the products use, the user must contact

Bard Access systems, Inc. to see if additional product information

is available.

Revision Date: December, 2011.

BARD DISCLAIMS ALL WARRANTIES, WHETHER

EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY

OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR

PURPOSE, AND BARD WILL NOT BE LIABLE TO PURCHASER

FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES

ARISING OUT OF USE OR HANDLING OF THIS PRODUCT.

*Bard and AirGuard are trademarks and/or registered trademarks

of C. R. Bard, Inc.

Bard Access Systems, Inc.

605 North 5600 West

Salt Lake City, Utah 84116 USA

801-522-5000

Clinical Information Hotline: 1-800-443-3385

Ordering Information: 1-800-545-0890

www.bardaccess.com

0732800 1112R

ACCESS SYSTEMS

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