Aeris Ballon-Dilatationskatheter Gebrauchsanweisung Seite 5

NOTE: The balloon on the Aeris
present two hubs proximally and distally on the balloon. This is to help secure the
balloon in place during inflation. The body of the balloon will increase to create a
uniform diameter balloon at recommended inflation pressure. This should be
considered an adjunct to the procedures and actions normally taken to prevent
slippage in either direction of the intended area to be dilated. Firm control of the
balloon catheter should be maintained during the entire procedure.
5. Remove the Airway Stylet, if it has not been removed already, and attach the
balloon dilation catheter luer to the connecting tube of the Inflation Device
with gauge to monitor balloon pressure.
6. Inflate the balloon with sterile water to desired pressure. Monitor the balloon
pressure using the gauge on the inflation device. Visualize endoscopy during
inflation of the balloon assessing the diameter, shape and the position of the
balloon. Ensure the proximal end of the balloon remains proximal to the stricture
throughout inflation.
WARNING
Do not exceed the Maximum Inflation Pressure stated on the label or in product
table in the Device Description section of this Instructions for Use.
If the balloon moves distally or proximally, out of position, at any time during the
procedure do not hold the balloon against any resistance. Deflate the balloon and
reposition to desired position. Once the balloon has been repositioned re-inflate.
Holding the balloon against resistance may damage the balloon dilation catheter
or anatomy. If the balloon does not deflate rupture the balloon with a sharp instrument
to allow removal.
NOTE: If the balloon ruptures at any time during the procedure, identified by a
rapid decrease in pressure on the inflation gauge or visually. Carefully, deflate the
balloon and remove the balloon dilation catheter.
7. As dilation takes place the pressure readings may fluctuate. Adjust the balloon
pressure as necessary to meet the desired target.
PRODUCT
NUMBER
KG0530
KG0630
KG0730
KG0830
KG0930
KG1030
KG1240
KG1440
KG1640
KG1840
WITHDRAWING THE BALLOON DILATION CATHETER
1. To deflate maintain an endoscopic view of the proximal end of the balloon as
vacuum is applied using the inflation/deflation device. Completely deflate the
balloon, using vacuum, before pulling back on the balloon dilation catheter.
Visually confirm endoscopiclly the balloon is deflated before removing the
balloon dilation catheter.
2. If additional inflations are required, slightly inflate the balloon using fingers
gently re-wrap the airway balloon in a clockwise motion, compressing the
balloon starting at the distal end of the balloon working back as you apply
vacuum. Use the inflation device to apply vacuum.
NOTE: After the balloons first inflation the hubs on the distal and proximal ends
of the balloon may not appear upon inflation.
NOTE: Only advance or withdraw the balloon dilation catheter when the balloon
is completely deflated and without the green protective sheath covering the balloon.
Advancing the balloon partially or fully inflated may cause serious damage to anatomy
or the device.
NOTE: Do not rotate the balloon dilation catheter after placing it into the patient.
3. Dispose of the catheter in accordance with accepted hospital guidelines.
® balloon dilation catheter will upon initial inflation
BALLOON SIZE
(diameter x length)
5 x 30 mm
6x 30 mm
7x 30 mm
8 x 30 mm
9 x 30 mm
10 x 30 mm
12 x 40 mm
14 x 40 mm
16 x 40 mm
18x 40 mm
MAXIMUM
INFLATION
PRESSURE
17 atm
17 atm
17 atm
17 atm
17 atm
17 atm
10 atm
10 atm
10 atm
10 atm
INFLATION DEVICE/
SYRINGE VOLUME
10 cc
10 cc
10 cc
10 cc
10 cc
20 cc
20 cc
20 cc
20 cc
20 cc
3