B. Braun VenaTech RETRIEVABLE 04435150, Instructions For Use Manual

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Warning:
Before filter implantation, the diagnosis must be confirmed and the co-morbidity factors must be evaluated.
Note:
All basic materials for venipuncture and supplies for pre-placement cavogram are not included in this kit:
- Scalpel
- Puncture (Seldinger) needle
- Angiography catheter or other catheter of your choice
- “J” guidewire
A) Preparation of the implantation accessories
1. The filter is pre-loaded in its cartridge. Load the cartridge into the cradle (Fig. 1).
Warning:
- A “click” must be heard to guarantee complete insertion of the cartridge into the cradle (Fig. 2).
- The side window of the cradle must read “FEMORAL” (Fig. 2).
2. Flush the assembly with heparinized saline.
Note:
This precaution reduces the possibility of thrombus formation around the filter during its movement
through the introducer sheath.
B) Puncture of the vein
1. Prepare the patient for access from the femoral approach. Operate under conditions of strict asepsis.
2. Puncture the vein using the Seldinger technique (or perform a surgical cut-down of the vein). Confirm
venous reflux into the syringe.
3. Advance a guidewire (0.035” — 0.89 mm) and then remove the Seldinger needle.
C) Control cavogram marking the filter implant site
1. Create a small incision with a scalpel to facilitate the passage of the introducer. Insert a catheter
introducer over the guidewire. Remove the guidewire. Introduce an angiographic catheter or catheter of
choice through the introducer catheter and perform a cavogram.
Warning: If an ilio-caval clot is present, extreme care must be taken to avoid dislodging the clot.
2. Locate the renal veins and select the location for filter placement. Mark the planned position of the top of
the filter cone by placing a metallic marker (e.g. hemostat) horizontally across the abdomen.
Note: When choosing the site for filter deployment, it is mandatory to place the filter below the renal
veins. A security margin of 0.5 cm should be left from the level of the lowest renal vein to the top of the
filter in case of filter movement. (Fig. 17).