En - English - SOMATEX Tumark MRI Gebrauchsanweisung

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Tumark MRI
E N - E N G L I S H
Important Information:
Read this instruction manual thoroughly and be familiar with its contents prior to use. Failure to read the entire
manual and familiarize yourself with all instructions before using the Tumark
threatening or severe injury to the patient or user and to damage or malfunction of the device.
Indications:
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The Tumark MRI is intended for the percutaneous marking of soft tissue, particularly breast tissue.
Among its areas of application are especially the marking of lesions prior to or during chemotherapy, pinpointing
the site of a biopsy or the removal of a tumor, or prior to radiotherapy for better treatment planning.
It is intended to be used with magnetic resonance imaging (MRI) techniques.
Contraindications:

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The Tumark MRI is only intended for the use indicated above.

The use of the Tumark
Warnings:
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Only qualified physicians with knowledge, experience and training in percutaneous soft tissue marking
should use the Tumark
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Only qualified physicians with knowledge, experience and training in MR Imaging should use
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Tumark MRI in Magnetic Resonance Imaging (MRI) procedures.

This manual does not include descriptions or instructions for surgical techniques. It is the responsibility of
the physician performing any procedure to determine the appropriateness of the type of procedure to be
performed and the use of this product and to determine the specific technique for each patient.

When implanting a marker near a breast implant, handle with care to avoid puncturing the implant.
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Before use, ensure that the package has not been opened and/or damaged. In addition, check the
sterilization expiration date. If the packaging has already been opened or damaged or if the sterile date has
expired, the product must NOT be used.

Single patient use only. DO NOT reuse or resterilize.

Note that the size of the image artifact depends on the sequence and the orientation towards the B
Therefore the actual position of the cannula tip may differ from the position of the artifact tip.
Precautions:
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Make sure that the slide-button does not change its backward position while placing the cannula.

The marker must be placed by pushing the slide-button forward as far as possible.
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Cannula tip is sharp. Use care especially while unpacking the cannula.
MRI Safety Information:
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The Tumark
application system or the marker under the following conditions:
o static magnetic field of 1.5 Tesla and 3.0 Tesla with
o theoretically estimated maximum – averaged across the whole body – specific absorption rate
MR
conditional
(whole body averaged SAR) of 2 W/kg for scanning of 20 minutes.
Non-clinical tests were performed on the following systems:

3 Tesla Siemens Magnetom Trio (Siemens Medical, Erlangen, Germany) MRI with Software Numaris
4, syngo MR (Version "B15, N4_VB15A_LATEST_20070519_P12"),

1.5 Siemens Magnetom Avanto (Siemens Medical, Erlangen, Germany) MRI with Software Numaris 4,
syngo MR (Version "B13, N4_VB13A_LATEST_20060607_P29").
Under the scanning conditions defined above, it is expected that the Tumark
maximum HF-conditional temperature rise after 20 minutes of continuous scanning:

Application system with 1.5 Tesla: 1.41 °C (2 W/kg SAR)
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Application system with 3.0 Tesla: 1.07 °C (2 W/kg SAR)
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Clip Marker with 1.5 Tesla: <1 °C (2 W/kg SAR)
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Clip Marker with 3.0 Tesla: <1 °C (2 W/kg SAR).
Under the scanning conditions defined above, it is expected that the Tumark
maximum image artefacts:

Application system with 1.5 Tesla: 13.4 mm spin echo sequence, 8.9 mm gradient echo sequence
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Application system with 3.0 Tesla: 52.1 mm spin echo sequence, 47.8 mm gradient echo sequence
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Clip Marker with 1.5 Tesla: 7.1 mm spin echo sequence, 6.5 mm gradient echo sequence
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Clip Marker with 3.0 Tesla: 9 mm spin echo sequence, 6.5 mm gradient echo sequence.
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MRI is contraindicated in patients who suffer from a severe nickel allergy.
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MRI.
MRI is conditionally MR safe. A patient can safely undergo an MRI procedure with the
6/28
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MRI is unsafe and can result in life
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MRI will produce the following
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MRI will produce the following

EN - ENGLISH

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