Bard AirGuard User manual

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.
© 2011 C. R. Bard, Inc. All rights reserved.
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, Utah 84116 USA
801-522-5000
Clinical Information Hotline: [phone]
Ordering Information: 1-800-545-0890
www.bardaccess.com
0732800 1112R
ACCESS SYSTEMS