3
3. Flush the assembly with sterile saline.
4. Access the desired vessel.
5. Place a guidewire into the vasculature according to the device’s instructions for use
(0.014 to 0.035-in [0.36 to 0.89-mm]).
6. Advance the prepared delivery catheter over the guidewire until the delivery catheter is
positioned according to the device’s instructions for use.
7. Remove the guidewire. Allow back-bleeding to purge any air from the delivery catheter.
8. Flush the loader assembly ( self-sealing hemostasis valve) with heparinized
saline.
9. Capture the device to be implanted in the loader assembly according to the device's
instructions for use.
10. Insert the distal end of the loader into the proximal end of the Tuohy-Borst hemostasis
valve and advance into the delivery catheter until it stops. Tighten the hemostasis valve
to lock the components together and remove any air that may have entered the
delivery catheter system by aspirating and flushing with heparinized saline.
11. Hold the delivery catheter, Tuohy-Borst hemostasis valve, and loader assembly as a
unit. Move the device to be implanted from the loader into the catheter.
CAUTION: Move the device to be implanted carefully to prevent damage to the vessels
or cardiac tissue.
Note: If it is difficult to transfer the device to be implanted into the catheter, recapture
the device in the loader and adjust the position of the loader.
12. Deploy the device to be implanted according to the instructions for use supplied with
the device.
13. When the procedure is completed, remove the delivery wire and the catheter.
WARNING: Slowly remove the delivery catheter from the patient to prevent the
introduction of air.
Disposal
• The instructions for use are recyclable. Dispose of all packaging materials appropriately.
• Dispose of device and accessories following standard solid biohazard waste procedures.
• Devices can be returned to Abbott Medical for disposal. Contact an Abbott Medical
representative or [email protected] for instructions.
Warranty
Abbott Medical warrants to buyer that, for a period equal to the validated shelf life of the
product, this product shall meet the product specifications established by the manufacturer
when used in accordance with the manufacturer’s instructions for use and shall be free from
defects in materials and workmanship. Abbott Medical’s obligation under this warranty is limited
to replacing or repairing at its option, at its factory, this product if returned within the warranty
period to Abbott Medical and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, ABBOTT MEDICAL DISCLAIMS
ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
See the Terms and Conditions of Sale for further information.
For U.S. --- California Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is
known to the State of California to cause cancer and birth defects or other reproductive
harm. For more information, go to www.P65Warnings.ca.gov.
