How Supplied; Device Details; Handling And Storage; Operational Instructions - Boston Scientific Hurricane Rx Gebrauchsanweisung

HOW SUPPLIED

Device Details

The Hurricane RX Biliary Balloon Dilatation Catheter is supplied
sterile using an ethylene oxide (EO) process.
Do not use if package is damaged or unintentionally opened
before use.
Do not use if labeling is incomplete or illegible. If damage is found,
call your Boston Scientific representative. See product label for
expiration date.

Handling and Storage

This product has no special handling or storage requirements.

OPERATIONAL INSTRUCTIONS

Inspection and Preparation

Precaution: The Hurricane RX Biliary Balloon Dilatation Catheter
is packaged sterile in a pouch. Before using, inspect the pouch for
any breach of the package to ensure a sterile product.
1. Prior to use, carefully examine the unit to verify that the
2. Remove plastic mandrel from distal end of catheter.
3. Close FloSwitch Adapter attached to injection hub.
4. Prepare balloon inflation syringe with contrast medium*.
5. Attach balloon inflation hub to inflation syringe with a gauge to
6. To maximize endoscope passage, apply a vacuum to the catheter
7. Remove protective sleeve from balloon prior to insertion.
8. For Contrast Injection: Prime second syringe (10 ml (cc)

Catheter Insertion

The Hurricane RX Biliary Balloon Dilatation Catheter is designed to
pass through a duodenoscope with a minimum 3.2 mm working
channel. Each catheter's working length is 180 cm. The balloon
should be advanced over the guidewire and through the scope
channel using short, deliberate 2-3 cm movements to prevent
inadvertent kinking of the catheter shaft. Fluoroscopy can be used
to confirm proper placement.
1. The Hurricane RX Biliary Balloon Dilatation Catheters are to be
2. Ensure the RX locking device is firmly seated onto the
37 MB Drawing 50573137
catheter or sterile package has not been damaged in shipment.
Precaution: Do not remove stylet from proximal injection hub
as the stylet is not intended to be removed from the device.
Attempting to remove the stylet may cause device damage.
monitor pressure.
before removing protective sleeve from the balloon section of
the catheter. Close stopcock, disconnect syringe from stopcock,
remove air from syringe and reconnect to balloon hub.
recommended) with contrast medium* and attach to FloSwitch
Adapter, open FloSwitch Adapter and flush if needed.
* Note: Commercially available contrast fluids have different
viscosities that may affect balloon inflation and deflation
performance as well as distal contrast injection performance.
The higher the viscosity (thicker) the slower the fluid will move
through the catheter. Dilute the contrast fluid with saline
as required to improve inflate-deflate time as well as distal
contrast injection performance.
Warning: To ensure minimum balloon profile, do not pre-
inflate, pretest balloon, or attempt to refold balloon into
protective sleeve as this could lead to device damage and/or
patient injury.
used with a Boston Scientific RX locking device.
endoscope against the side of the working channel port.
5
Black (K) ∆E ≤5.0