Boston Scientific Alliance II Instrucciones De Uso página 3

has been damaged during shipment. DO NOT USE if damaged.
Immediately return the damaged product to Boston Scientific.
INSTRUCTIONS FOR USE FOR DILATATION
1. To insert the Alliance II Syringe/Gauge Assembly into the
Alliance II Integrated Inflation/Litho Handle, turn the blue
directional switch to the upward position. Align the syringe
flanges with the slot in the handle and align the back of the
syringe plunger with the slot in the heel plate. Push down on
the Syringe/Gauge Assembly firmly to insure proper fit. Snap
the heel clip over the syringe plunger. Move the heel plate and
syringe plunger all the way forward.
Note: Improper Syringe/Gauge Assembly alignment may cause
inability to properly inflate the balloon.
Optional: Extension tubing is provided for your added
convenience. If using the extension tubing, connect to the Syringe/
Gauge Assembly and the balloon catheter hub using the Luer-Lok®.
2. Turn the blue directional switch backward toward the red arrow.
Pump the handle lever to fill the Syringe/Gauge Assembly with
35 ml of sterile water for balloons up to a 20 mm diameter.
Note: NEVER use air or any gas medium to inflate the balloon
catheters. Maximum dilatation results are achieved using fluids.
3. Purge excess air from the Syringe/Gauge Assembly by turning
the blue directional switch forward toward the green arrow,
tilting the assembly so that the air bubbles float towards the
Luer-Lok end and pumping the handle lever until all air is
purged from the syringe.
4. Attach the balloon catheter hub to the Syringe/Gauge Assembly
or to the extension tubing via the Luer-Lok.
5. Pull a vacuum on the balloon catheter by moving the blue
directional switch backward toward the red arrow and pump the
handle lever until it stops.
6. Remove the protective sleeve from the balloon.
Optional: Apply silicone spray to the balloon to facilitate
passage through the endoscope.
Note: DO NOT pre-inflate or pre-test the balloon.
7. To inflate the balloon, move the blue directional switch forward
toward the green arrow, holding the Alliance II Integrated
Inflation System at a downward angle to prevent air from
entering the balloon.
8. Pump the handle lever until the gauge on the Syringe/Gauge
Assembly registers pressure.
Note: Refer to the balloon package label for the maximum
rated balloon pressure. The gauge will read pressure in both
atmospheres (ATMs) and kilopascals (kPa).
9. Continue inflation until the desired pressure is achieved.
PRECAUTION: DO NOT exceed the maximum balloon pressure
specified on the balloon.
10. To deflate, turn the blue directional switch backward toward the
red arrow and pump the handle lever until it stops.
Note: The blue directional switch may be harder to turn when
the Syringe/Gauge Assembly is inflated to high pressures.
PRECAUTION: Slide arm may retract rapidly when used with
balloons rated above 5 ATM (507 kPa).
11. Return the blue directional switch to the upward position to
detach the balloon catheter.
DIRECTIONS FOR USE WITH LITHOTRIPSY
1. To attach the Trapezoid RX Wireguided Retrieval Basket to
the Alliance II Integrated Inflation/Litho Handle, turn the blue
directional switch to the upward position.
2. Align the thumb ring and the handle ring with the heel plate
and body portion of the Alliance II Integrated Inflation/Litho
Handle respectively.
3. Push the basket handle down into the Alliance II Integrated
Inflation/Litho Handle until secure.
3
Black (K) ∆E ≤5.0