Instructions For Use (English) - SOMATEX Duo System Premium Gebrauchsanweisung

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
Intended use:
The product is intended as a preoperative marker of non-palpable suspected breast lesions to facilitate the intraoperative localization of
the findings by the surgeon.
Contraindications:
All contra-indications applicable to the relevant area of application, as known according to the rules of the art of medicine and
anticipated for the use of cannulas and marker systems for preoperative marking of breast lesions, shall apply.
Possible known complications:
Wire dislocation, accidental cutting of wire, wire break, bleedings, infections, aesthetic complications
Warnings:

Only qualified physicians with the required knowledge, experience and training shall use the product.

This manual does not include descriptions or instructions for surgical techniques. It is the responsibility of the physician performing
any procedure to determine the appropriateness of the procedure to be performed and of the use of this device and to determine
the specific technique for each patient.

The product is only sterile, if used before the expiration date and if package is unopened and undamaged. DO NOT use after the
expiration date or if package is open or damaged.

The product is NOT suitable for MRI use (magnetic resonance imaging)! Danger of injury!

Single patient use only. DO NOT reuse or resterilize.
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 can 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.
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 the product properly in a suitable container.
Storage:
Protect from moisture. Keep dry.
Keep away from sunlight and heat (temperature 5 – 30 °C / 41 – 86 °F).
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