SOMATEX Tumark MRI Gebrauchsanweisung Seite 7

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Tumark MRI
Device Description:
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The Tumark MRI is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable
nickel-titanium marker (1), an introducer cannula (2) and a plastic handle. The introducer cannula is designed with
a beveled tip for convenient introduction and 1 cm depth marks to aid in cannula placement. The handle is equipped
with a slide-button (3) which allows for a one-handed placement of the marker by pressing it forward, after the
fixation clip (4) has been removed. A safety catch system prevents the slide-button to inadvertently move forward
and therefore prevents a premature deployment of the marker. The clip marker is in a U-form (1).
1
Directions for Use:
1. Before use, ensure that the package has not been opened and/or damaged. In addition, check the
sterilization expiration date.
2. Open the package.
3. Disinfect the puncture area and cover it with sterile drapes.
4. Locate the target area by using appropriate MR imaging systems.
5. Remove the fixing clip (4) from the handle.
6. Puncture the target area with the cannula (2) and insert the cannula into the tissue. The depth marks can
assist you while positioning the cannula to the target.
7. Confirm the needle placement with appropriate MR imaging systems. If necessary correct the placement.
8. Place the marker (1) by firmly pushing the slide-button (3) forward as far as possible.
9. Confirm and document the location of the marker (1).
10. Remove the cannula (2).
11. Treat the wound.
12. After the procedure, please ensure the appropriate disposal of the cannula (2) in the proper cannula
container.
Warning:
The company SOMATEX does not assume any liability for the use of this product or its components in case of re-
sterilisation 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 sterilisation 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 with a temperature between 5 – 30 °C (41 – 86 °F).
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2
Schematic representation
Dimensions: U-form
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