B. Braun VenaTech RETRIEVABLE 04435150, Instructions For Use Manual

Page: 10 / 106

8
H) Deployment of the filter
Warning: All the following steps of the filter deployment procedure must be done under fluoroscopic
guidance.
1. Final adjustment of the filter position prior to deployment: align the top of the filter cone with the
metallic (radiopaque) marker placed on the patient at the beginning of the procedure.
2. Once the filter has reached the proper level for deployment, be careful not to move the introduction
system.
3. Confirm that the sheath has not moved and that the filter is properly positioned at the desired level for
implantation and centered in the IVC lumen.
4. Holding the pusher in one hand, take the sheath in the other hand and withdraw the sheath. This
movement deploys the filter. (Fig. 15, Fig. 16).
Never push the pusher to release the filter.
Warning:
To assure correct filter position, it is extremely important not to move the pusher :
• During the step prior to filter deployment
• During filter deployment
To limit potential tilting of the filter, the sheath must be centered in the IVC lumen before final deployment.
5. The filter is now implanted (Fig. 17).
Warning: Never try to re-position the filter after deployment.
Note: To perform a control cavogram after deployment of the filter:
A. Remove the long pusher while keeping the sheath in place.
B.Perform the cavogram by manually injecting contrast media through the side connection.
6. Remove the sheath after cavogram.
I) Final documentation
Take a final Kidneys, Urethra, Bladder (KUB) film which documents the location and deployment of the filter.
Note: The filter can be retrieved up to 12 weeks after implantation. Please use the dedicated VenaTech®
Retrievable System (Ref. 04435170) in case of retrieval
.
IMPORTANT
Vena Cava Filter for temporary or permanent filtration of the Inferior Vena Cava. STERILE and non-pyrogenic.
Sterilized using Ethylene Oxide. FOR SINGLE USE ONLY. The device and its accessories are not reusable nor
designed to be re-used. Any re-use would definitely compromise the performance and safety of the device.
After use, the VenaTech® RETRIEVABLE, Vena Cava Filter System and accessories may be a potential biohazard.
Handle and dispose of in accordance with the current medical practice and applicable laws and/or regulations.
COMPONENTS MAY NOT BE CLEANED OR RE-STERILIZED. Store at room temperature. Avoid freezing and
excessive heat. Do not remove from unit carton until ready for use.
Opening the sterile packaging:
Check that the sterile packaging is undamaged before opening. Confirm the date of sterile expiration on the
labeling. Never implant an IVC filter which has exceeded its sterile expiration date. To maintain sterility, all
normal aseptic room sterile procedures should be followed.
VenaTech® RETRIEVABLE
Vena Cava Filter System Reference: 04435150
B. Braun Medical
204, avenue du Maréchal Juin - BP 331
92107 Boulogne Cedex - FRANCE
Information: Fax: 33 5 49 52 88 77