Balloon Inflation; Catheter Withdrawal - Boston Scientific Hurricane Rx Gebrauchsanweisung

3. With the 0.035 in (0.89 mm) guidewire positioned and locked
into place, backload the Hurricane RX Biliary Balloon Dilatation
Catheter over the guidewire. Slide the Hurricane RX Biliary
Balloon Dilatation Catheter onto the guidewire and through
the first 25 cm until the guidewire exits the proximal end of the
black sleeve. Grasp the guidewire and slide the catheter over
the guidewire until it reaches the RX locking device.
4. Unlock the guidewire from guidewire locking device. Pass the
distal 25 cm section of the catheter past the guidewire locking
device while maintaining tension on the guidewire. Lock the
guidewire into place and continue advancing the
Hurricane RX Biliary Balloon Dilatation Catheter through the
scope until cannulation is achieved.
5. Two radiopaque markers located under the dilatation section of
the balloon will aid in positioning the catheter while
using fluoroscopy.
6. Contrast medium can be injected through the FloSwitch Injection
Port to visualize the bile duct if needed. The FloSwitch Adapter
must be opened prior to injection. The guidewire tip may be
pulled back into the catheter to help facilitate contrast injection.
Note: Use caution if retracting wire for aid in contrast injection.
Retracting the guidewire tip more than 20 cm into the catheter
tip may facilitate loss of guidewire cannulation through the
Hurricane RX Biliary Balloon Dilatation Catheter.

Balloon Inflation

Under fluoroscopic guidance, the balloon should be advanced and
positioned across the stricture to be dilated. The balloon can be
inflated by means of a hand-held syringe.
Warning: To prevent balloon burst and patient injury, do not
exceed the inflation pressure given for the diameter on the
catheter's package label. If the balloon does rupture or a significant
loss of pressure within the balloon occurs, deflate the balloon
completely and carefully remove the balloon and endoscope
together as a unit. Do not attempt to withdraw a ruptured balloon
through the endoscope. Continue procedure with a new catheter.
It is recommended that a 10 ml (cc) or larger syringe with a gauge
to monitor balloon pressure be used when inflating a Hurricane RX
Biliary Balloon Dilatation Catheter. The typical inflation medium is a
1:1 mixture of contrast medium and normal saline.
Precaution: Do not use air or a gas medium to inflate the balloon
as this will result in reduced balloon effectiveness.

Catheter Withdrawal

1. When dilatation has been completed, deflate the balloon by
applying suction to the balloon lumen.
2. Do not pull back on the catheter until the balloon is
completely deflated.
Warning: The balloon must be thoroughly deflated, and
all fluid removed prior to withdrawal in order to prevent
patient injury and/or damage to the device (up to 30 seconds
depending on inflation medium).
3. Slowly remove the catheter from the endoscope.
Warning: If excessive resistance is felt, remove the endoscope
and balloon catheter together as a complete unit to prevent
damage to body tissue, the catheter, or the endoscope.
4. The catheter should be disposed of in accordance with accepted
hospital guidelines.
Black (K) ∆E ≤5.0
6
MB Drawing 50573137