Aeris Ballon-Dilatationskatheter Gebrauchsanweisung Seite 4

Do not use if package is opened or damaged. Do not use if labeling is incomplete
or illegible.
Appropriate anesthetic techniques to minimize respiratory effort should be used
before this device is used. Negative pressure pulmonary edema may result in patient
as a result of ongoing vigorous respiration while the balloon is dilated and the
airway occluded.
Careful monitoring of patients oxygen levels is necessary during balloon dilation.
Hypoxia may occur as a result of extended periods of occluding the airway.
During dilation caution should be used to avoid any interference and possible
obstruction of other devices such as tracheostomy tubes and endotracheal tubes.
Compatibility of this device has not been determined for use within the working
channel of a bronchoscope.
The balloon must be inflated with sterile water.
Do not pretest or preinflate the balloon.
The catheter lumen is occluded at the distal end and cannot be used to ventilate.
Use of a balloon that is too large for the target anatomy and may cause damage to
the surrounding anatomy.
Use of an undersized balloon may result in failure to properly treat the target anatomy.
Do not try to force movement of the balloon catheter if balloon is inflated.
If the balloon catheter migrates during inflation of the balloon do not attempt to
advance or retract the balloon without deflating the balloon first.
Do not advance, retract, or hold the balloon catheter or balloon catheter with stylet
against resistance. Tissue damage or tissue trauma may occur as a result.
Do not advance, retract, or hold the balloon catheter or the balloon catheter with
stylet against resistance as damage to the device may occur.
If at any point during the procedure the balloon does not deflate rupture the balloon
with a sharp instrument to allow removal.
Position balloon catheter properly by using direct visualization. Improperly inflating
the balloon in the incorrect location may harm the patient.
The Aeris ® balloon dilation catheter is compatible with the Bryan Medical Inc. Inflation
Device.
INSTRUCTIONS FOR USE: PREPARATION
Before using inspect the pouch for any breach of the packaging to ensure sterile
product and that no damage has occurred to product during shipping.
Visualization of the airway using endoscopy or bronchoscopy, flexible or rigid is
recommended in order to determine the location of the stricture and guide placement
of the balloon.
Selection of the proper balloon size is critical such that the diameter of the balloon
fully inflated does not exceed the expected diameter of a healthy airway. Endoscopic
direct visualization or imaging can assist in determining a healthy airway diameter.
The cartilage skeleton i.e. tracheal rings should be taken into account in limiting
the balloon size.
A sharp instrument which can reach the site of dilation should be made available
in the event that difficulties arise during deflation of the balloon.
1. Open the sterile package and remove the airway balloon catheter with the
stylet in place.
2. If using the stylet confirm that it is locked in place onto the luer at proximal
end of the balloon dilation catheter. If not, unlock the stylet, remove and place
aside.
3. Prepare the Bryan Medical Inflation Device.
4. Remove the green protective sheath that covers the balloon.
5. Wipe the outer surface of the balloon and catheter with sterile water soaked
gauze pad.
PLACEMENT
1. Locate the stricture using, flexible or rigid, bronchoscopy or endoscopy.
Fluoroscopy may be used to confirm balloon placement. Two radiopaque
markers are located on the catheter inside the balloon.
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2. The Aeris
and locked for shaping. Kinking may occur without Stylet locked in place.
3. Under endoscopic visualization slowly and gently advance the Airway Balloon
to the site of the stricture.
4. Center the balloon portion of the device across the area to be dilated. The
proximal end of the balloon should be positioned proximal to the stricture.
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Balloon may be shaped if desired. The Airway Stylet must be in place