2
7.
If the loop is not perpendicular to the shaft when extended from the sheath, completely retract the loop into the sheath and re-extend catheter.
8.
The catheter should be passed from a peripheral vessel to the desired endocardiac position with the aid of fluoroscopy. Compatible navigation and
visualization systems may be used in conjunction with fluoroscopy.
9.
To adjust the curve of the distal tip on the uni-directional catheter, push or pull the thumb control located on the handle. To adjust the curve of the
distal tip on the bi-directional catheter, use the actuator to deflect the catheter in either direction.
NOTE: The bi-directional handle has an adjustable tension control knob that allows the operator to use the actuator and deflectable section in an
unlocked state or adjust the tension to where the actuator and deflectable section are locked in place. The amount of friction increases as the
knob is rotated clockwise until it reaches the fully plus (+) position.
NOTE: The uni-directional handle has an adjustable tension control knob that allows the operator to use the actuator and deflectable section in an
unlocked state or adjust the tension to where the actuator and deflectable section are locked in place. If necessary, the tension control knob may
be rotated to increase or decrease the tension.
10.
Prior to withdrawal, deflect catheter shaft to straight position. Re-insert the loop straightener into the hemostasis valve prior to removing the catheter
from the introducer.
11.
After use, dispose of product and packaging in accordance with hospital, administrative, and/or local government policy.
Connection to Other Equipment
The catheter may be connected to a commercially available EP recording system and navigation and visualization system using the connection cable. All
systems must be patient isolated. For instructions regarding the use of these systems with the catheter, refer to the system’s instructions for use.
Packaging and Shelf-Life
The catheter packaging is designed to prevent crushing of the product, to minimize product exposure to the atmosphere, and to provide for aseptic product
transfer. It is recommended that the product remain in the unopened package until time of use. Contents are sterile if the package is unopened and
undamaged. Do not resterilize. The expiration date is marked on the outside of the package. The product should be stored in a cool, dry location. The
instructions for use is recyclable. Dispose of used product and packaging following standard solid biohazard waste procedures.
To remove the catheter from its tray, remove the handle retainer from the tray then lift the catheter up and out of the tray. See Figure 1.
Figure 1.
Warranty
Abbott Medical warrants that its products shall be free from defects in materials and workmanship under normal use. This warranty does not exceed the
"Expiration" date stated on any product labeling. The authorized uses and approved methods of use of each of our products is set forth in the related
"Instructions for Use" that accompany each product. Abbott Medical disclaims any responsibility and liability for the use of its products in a manner that has
not been authorized or approved. Abbott Medical’s liability under this warranty is limited to replacing its products. The foregoing warranty excludes and is in
lieu of all other warranties whether expressed or implied including, but not limited to, any implied warranties of merchantability or fitness for a particular
purpose. Abbott Medical disclaims any liability for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this
product, other than as expressly provided by specific law. Abbott Medical neither assumes nor authorizes any other person to assume for it any other or
additional liability for loss, damage, or expense in connection with this product. For more details please review complete Abbott Medical warranty policy
available from Abbott Medical or on the back of an Abbott Medical invoice.
Symbols
NOTE: The symbols section contains all the symbols that may be used on product labels. Product is labeled as required.
Symbol
Description
Caution, consult accompanying documents
Quantity
Keep dry
Keep away from sunlight
Catalog number
