SOMATEX TUMARK Q Instrucciones De Uso página 6

®
Tumark Q
Under the scanning conditions defined above, it is expected that clip marker of Tumark
image artefacts:

at 1.5 Tesla: 4,3 mm spin echo sequence; 3,2 mm gradient echo sequence,

at 3.0 Tesla: 4,7 mm spin echo sequence; 4,0 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:
®
The Tumark Q 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, 1 cm depth marks and an
ultrasound enhancement on the distal end 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 transparent 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.
1
Directions for Use:
1. Prior to opening the package, make sure 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 the area around it with sterile drapes if required.
4. Locate the target area by using appropriate imaging systems.
Note that the Tumark
marker itself, which has already been placed in a patient, can be exposed to a magnetic field of up to 3.0 tesla.
5. Remove the transparent locking clip (4) on the trigger (3).
6. Puncture the target area with the cannula (2) and insert the cannula into the breast. The depth marks can assist
you while positioning the cannula to the target.
7. Confirm the needle placement with appropriate 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:
Keep dry.
Keep away from sunlight and heat (temperature between 5 – 30 °C).
Schematic Illustration
Dimensions
® , as
Q applier of a clip marker, is not useable in MR imaging systems. Only the clip
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2
EN - ENGLISH
®
Q will produce the following
4
3