Preparations For Use - Merit Medical Torpedo Instrucciones De Uso

Other items required but not provided:
• 1 mL or 3 mL delivery syringe
• 50:50 contrast/saline sterile mixture for delivery
• Catheter with an inner diameter equal to or greater than the minimum I.D. listed for
delivery of the selected Torpedo size
STORAGE & STERILITY
• The Torpedo must be stored at room temperature in a dry and dark place in its original
packaging
• Use by the date indicated on the labeling
• Do not resterilize

PREPARATIONS FOR USE

Embolization with the Torpedo should only be performed by physicians who have received
appropriate interventional embolization training in the region to be treated.
1. Prior to use, carefully inspect the Torpedo packaging and components for damage.
2. Utilizing sterile technique, remove the Torpedo cartridges and blunt stylet from their
packaging and transfer to the sterile field.
3. Carefully evaluate the vascular network associated with the lesion using high resolution
imaging prior to beginning the embolization procedure.
4. Choose the appropriate size of Torpedo that best matches the pathology (i.e., vascular
target/vessel size) and provides the desired clinical outcome.
5. Choose a delivery catheter based on the size of the target vessel and the Torpedo size
being used.
6. Introduce the delivery catheter into the target vessel according to standard techniques.
Position the catheter tip as close as possible to the treatment site to avoid inadvertent
occlusion of normal vessels.
DEPLOYMENT PROCEDURE
The techniques and procedures described do not represent ALL medically acceptable
protocols, nor are they intended as a substitute for the physician's experience and judgment
in treating any specific patient. All available data, including the patient's signs and symptoms
and other diagnostic test results, should be considered before determining a specific
treatment plan.
THE TORPEDO CAN BE DELIVERED WITH OR WITHOUT THE USE OF BLUNT STYLET.
OPTION 1: TORPEDO DELIVERY WITHOUT BLUNT STYLET
1. Attach the female luer end of the Torpedo to the male luer of a 1 mL or 3 mL delivery
syringe filled with 50:50 contrast/saline sterile mixture.
Precaution: Only one (1) Torpedo should be delivered at a time. Delivering more
than one (1) Torpedo at a time may result in non-target embolization.
2. With the delivery syringe and attached Torpedo standing upright, gently depress the
plunger of the delivery syringe to remove air. The Torpedo cartridge has a debubbling
channel designed for air-free injection. Gently and slowly depress the plunger of the
delivery syringe until 2-5 drops of the contrast/saline sterile mixture come out of the
Torpedo tip.
3. Make an air-free connection between the Torpedo (still connected to the delivery
syringe) and the hub of the catheter that is positioned in the vasculature for
embolization.
4. Firmly depress the plunger on the delivery syringe to deliver the contrast/saline sterile
mixture and the Torpedo through the catheter and into the vasculature, observing the
delivery of the Torpedo under fluoroscopy. If the Torpedo does not exit after depleting
the entire volume of fluid in the delivery syringe, refill the delivery syringe with 50:50
contrast/saline sterile mixture and continue to deliver fluid until the Torpedo exits the
catheter.
5. If further embolization is desired, repeat steps 1-4 with additional Torpedoes.
6. Discard any empty Torpedo cartridges or unused devices, including the blunt stylet.