Instructions For Use (English); Contraindications - SOMATEX DUO-System PREMIUM Serie Bedienungsanleitung

DUO-System PREMIUM
I n s t r u c t i o n s f o r u s e ( E n g l i s h )
DUO-System PREMIUM
Correctable Localization Kit
The Somatex DUO-SYSTEM Premium is intended for pre-operative marking of nonpalpable, suspicious breast lesions to
facilitate intra-operative localisation by the surgeon.
Before use:
1. Make sure that the packaging has not been opened and/or damaged; check sterilisation date.
2. Open the packaging.
3. When the wire arches are visible, insert into the cannula by pulling the lever (Fig. 1, 2) back to the stop.
4. Check that the arches (Fig. 1, 1) have completely disappeared into the cannula.
Application:
5. Disinfect locally and apply local anaesthetic around the entry point.
6. If necessary, use a scalpel to make a stab incision at the puncture point, to facilitate penetration of the skin.
7. Place tip of cannula in the area to be marked.
8. Unfold the arches by moving the lever (Fig. 1, 2) sideways to the left, then pushing it all the way forward (Fig. 1, 3).
9. Note position of the wire. If the arches are not in the correct position, retract them again by pulling back the lever (Fig. 1,
3). Move the cannula tip into the desired position, re-extend the arches and note the new position of the arches.
10. Before removing the cannula, turn lever (Fig. 1, 4) to the right until it clicks into place. The lever will not now retract the
wire!
11. Carefully remove the cannula from the patient.
12. Relax the compression of the breast, if necessary. Slide the opened fixation part over the wire almost to the surface of the
skin of the breast (important: The breast must be decompressed when this is done. There must still be some space been
skin and fixation part). The wire must lie between the brackets (Fig. 2, 5a) of the fixation part. The wire is fixed through the
closure being locked in place (Fig. 2, 5b). This measure prevents the risk of change in position of the wire along the distal
end.
13. Dress the wound.
14. Dispose of the cannula appropriately.

Contraindications:

All the contraindications relevant to the particular field of application apply to use of the Somatex DUO-SYSTEM PREMIUM.
They are assumed to be known for cannula and marking systems for pre-operative marking of breast lesions, in accordance
with accepted medical practice.
Warning:
The company SOMATEX does not assume any liability for the use of this product or its components in case of re-sterilization or
reuse. This product may not be reused after a single application. The quality of the materials, coats and adhesive joints could
degrade. Safe use is not guaranteed any longer. The product that is already used once is not designed for the required cleaning
and sterilization processes. The sterility of the reprocessed disposable products is therefore not guaranteed. The risk of
unwanted injuries and infections, especially cross-infections between patient and medical staff inappropriately increases.
Storage instructions:
Store in a dark, dry place (humidity 30 – 65%) at a temperature between 41 and 86° F (5 – 30°C).
4/12 ENGLISH