SOMATEX TUMARK Professional Gebrauchsanweisung Seite 6

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Tumark Professional
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. A safety catch system prevents the slide-button to
inadvertently move forward and therefore prevents a premature deployment of the marker. The clip markers for
the Tumark® Professional are available in three different shapes: X-shape (4), U-shape(5) and Q-shape (6).
Instruments loaded with an X-shaped or Q-shaped clip show an X or Q on the handle. Instruments loaded with a
U-shaped clip do not have any special marking on the handle.
For details please refer to order numbers.
Behaviour of the clip marker in Magnetic Resonance Tomography (MRT):
®
Tumark Professional
The Somatex
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
Professional
, clip marker in an 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:
U-shape:
o
Static magnetic field of 3.0 tesla or less
o
Gradient field of 360 Gauss / cm or less
o
Maximum whole-body average SAR (Specific Absorption Rate) of 2 W/kg at scan duration of 20
minutes.
The behaviour of the clip marker in MRT has not been clinically tested under the following conditions:
Tumark
The clip marker of
maximum whole-body average SAR of 2 W/kg, determined by calorimetric measurement at an MRT scan duration
of 20 minutes in a 3 tesla Magnetom Trio (Siemens Medical, Erlangen, Germany) MRT with the Numaris 4, syngo
MR software.
In a non-clinical test with a 3 tesla Magnetom Trio (Siemens Medical, Erlangen, Germany) MRT using the
Numaris 4, syngo MR software, the image artefact of the clip marker amounted to 9.0 mm while using a spin echo
sequence, whereas 6.5 mm in case of gradient echo sequence.
X-shape:
o
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
minutes.
In a non-clinical test with a 3 tesla Magnetom Trio (Siemens Medical, Erlangen, Germany) MRT using the
Numaris 4, syngo MR software, the image artefact of the clip marker amounted to 2,7 mm while using a spin echo
sequence, whereas 3,7 mm in case of gradient echo sequence.
Q-shape:
o
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
minutes.
In a non-clinical test with a 3 tesla Magnetom Trio (Siemens Medical, Erlangen, Germany) MRT using the
Numaris 4, syngo MR 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.
Do not expose the implanted clip marker of the
standardized MRT-techniques than the ones listed above, because it has NOT BEEN TESTED for that purpose.
Directions for Use:
1. Prior to opening the package, 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 it with sterile drapes.
3. Locate the target area by using appropriate imaging systems. Note that the
useable in MR imaging systems.
, as applier of a clip marker, is not suitable for use in MRT, while the clip
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Professional
experiences an increase in temperature of less than 0.61 °C at a
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Professional
to other unconventional and non-
EN - ENGLISH
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Tumark
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Tumark Professional
is not