Boston Scientific Alliance II Instrucciones De Uso página 2

Alliance
™
Integrated Inflation/Litho Handle
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
DEVICE DESCRIPTION
The Alliance II Integrated Inflation/Litho Handle is a nonsterile,
reusable tool used with the sterile, single use Alliance II Syringe/Gauge
Assembly (sold separately), designed to simplify inflation and deflation
of balloon dilatation catheters. The Alliance II Integrated Inflation/
Litho Handle is also used with the sterile, single-use Trapezoid™ RX
Wireguided Retrieval Basket, which is supplied separately. When
assembled, the system is intended to aid in the crushing of gallstones
during endoscopic retrograde cholangiopancreatography.
The diagram shown below (Figure 1) describes the key components
of the Alliance II Integrated Inflation/Litho Handle when used with
the Syringe/Gauge Assembly. On the left side of the handle is a
blue directional switch that controls the movement of the Syringe/
Gauge Assembly plunger or the movement of the basket. Pumping
the handle lever inflates and deflates the balloon catheter or extends
and retracts the basket to crush the captured stone.
SYRINGE/GAUGE
ASSEMBLY
FORWARD
POSITION
EXTENSION
TUBING
Figure 1.
Black (K) ∆E ≤5.0
II
HEEL CLIP
DIRECTIONAL
SWITCH
HEEL
PLATE
BACKWARD
POSITION
INFLATION/
DEFLATION
HANDLE
HANDLE
LEVER
Contents
(1) Alliance II Integrated Inflation/ Litho Handle
SINGLE-USE SYRINGE/GAUGE ASSEMBLY
The Alliance Syringe/Gauge Assembly is a disposable syringe
pre-assembled with a disposable pressure gauge. The gauge is
graduated in both atmospheres (12 ATM maximum) and kilopascals
(1216 kPa maximum). The Syringe/Gauge Assembly is to be used
with the reusable Alliance II Integrated Inflation/Litho Handle when
performing balloon dilatation.
INTENDED USE / INDICATIONS FOR USE
The Alliance II Integrated Inflation/Litho Handle is indicated for inflation
and deflation of balloon dilatation catheters while simultaneously
monitoring balloon catheter pressures and for the crushing of biliary
calculi when used with the Trapezoid RX Wireguided Retrieval Basket.
Clinical Benefit Statement
To provide inflation and deflation of balloon catheters and to aid in
the crushing of calculi during ERCP procedures.
ADVERSE EVENTS
None known
HOW SUPPLIED
The Alliance II Integrated Inflation/Litho Handle is packaged with one
non-sterile Alliance II Integrated Inflation/Litho Handle.
Do not use if package is damaged or unintentionally opened before
use. Do not use if labeling is incomplete or illegible.
Handling and Storage
This product has no special handling or storage requirements.
Precaution: A thorough understanding of the technical principles,
clinical applications, and risks associated with balloon dilatation
and/or ERCP and mechanical lithotripsy is necessary before using
this product.
Inspect the Alliance II Integrated Inflation / Litho Handle for damage
and utility. Pump the handle lever to ensure the device's ability to
move in the direction indicated by the arrows. The Syringe/Gauge
Assembly component of the Alliance II Integrated Inflation/Litho
System is supplied EtO sterilized in a sealed tray. Carefully examine
the unit to verify that neither the contents nor the sterile package
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