SOMATEX Tumark Vision Gebrauchsanweisung Seite 6

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Tumark Vision
Under the scanning conditions defined above, it is expected that clip marker of Tumark
following image artefacts:

at 1.5 Tesla: 4.3 mm spin echo sequence; 5.2 mm gradient echo sequence,

at 3.0 Tesla: 5.2 mm spin echo sequence; 5.8 mm gradient echo sequence.
Do not expose the implanted clip marker to unconventional and non-standardized MRI techniques other
than the ones listed above, because it has NOT BEEN TESTED for that purpose.
Device Description:
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The Tumark Vision 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 introduction, 1 cm depth markings and a roughening before the cannula tip for better placement
with ultrasound imaging. The handle is equipped with a slide button (3) which allows one handed placement of the
marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward
and therefore prevents premature deployment of the marker. The clip marker has a spherical shape. The clip
shape is labelled on the handle.
Directions for Use:
1. Prior to opening the pack, make sure that the indicator on the package is green and that the package has not
been opened and/or damaged. In addition, check the sterilization expiration date.
2. Disinfect the puncture area and cover the area around it with sterile drapes if required.
3. Locate the target area by using appropriate imaging methods. NOTE: the Tumark
suitable for MRI scans.
4. Pull the protective tube from the cannula hub with a twisting movement.
5. Puncture the target area with the cannula (2) and insert the cannula into the tissue. The puncture depth can
be measured by the marks on the cannula when the cannula tip is being positioned.
6. Confirm the needle placement with appropriate imaging systems. If necessary correct the placement.
7. Place the marker (1) by firmly pushing the slide-button (3) forward as far as possible to stop position.
8. Confirm and document the location of the marker (1).
9. Remove the cannula (2).
10. Treat the wound.
11. 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:
Keep dry.
Keep away from sunlight and heat (temperature between 5 – 30 °C).
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Vision will produce the
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Vision cannula is not