Idiomas disponibles
Idiomas disponibles
Q
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TUMARK
Behaviour of the clip marker in Magnetic Resonance Tomography (MRT):
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Tumark
Q
The Somatex
, as applier of a clip marker, is not suitable for use in MRT, while the clip marker itself,
which has already been placed in a patient, can be exposed to a magnetic field of up to 3.0 tesla, for instance in
follow-up examinations. With regard to the interactions of the clip marker with the magnetic field (dislocation,
heating), there are no additional dangers or risks to a patient with incorporated
MRT with 3.0 tesla or less
The implanted clipmarker itself can be subjected to an MRT procedure under the following conditions without any
risk:
Static magnetic field of 3.0 tesla or less
o
Gradient field of 542 Gauss / cm or less
o
Maximum whole-body average SAR (Specific Absorption Rate) of 2 W/kg at scan duration of 20
o
minutes.
Do not expose the implanted clip marker of the
techniques than the ones listed above, because it has NOT BEEN TESTED for that purpose.
The behaviour of the clip marker in MRT has not been clinically tested under the following conditions:
In a non-clinical test with a 3 tesla Magnetom Skyra (Siemens Medical, Erlangen, Germany) MRT using the
Numaris 4, syngo MR D11 software, the image artefact of the clip marker amounted to 4,7 mm while using a spin
echo sequence, whereas 4,0 mm in case of gradient echo sequence.
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 it with sterile drapes.
4.
Locate the target area by using appropriate imaging systems.
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Tumark
Note that the
marker itself, which has already been placed in a patient, can be exposed to a magnetic field of up to 3.0
tesla.
5.
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.
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.
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:
Store in a dark, dry (humidity 30% - 65%) place with a temperature between 41° - 86° F (5° – 30°C).
-5-
®
Tumark
Q, as
applier of a clip marker, is not useable in MR imaging systems. Only the clip
Tumark
Q
to other unconventional and non-standardized MRT-
®
Q
clip marker in an
