En - English - SOMATEX Tumark Vision MRI 601590 Gebrauchsanweisung

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Tumark Vision MRI
E N - E N G L I S H
Read instructions before use
Important Information:
Read this instruction manual thoroughly and be familiar with its contents prior to use. Failure to read the entire
manual and to familiarize yourself with all instructions before using the Tumark
in life-threatening or severe injury to the patient or user and in damage or malfunction of the device.
Intended use and indications for use:
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The Tumark Vision MRI is intended for the percutaneous marking of soft tissue, such as breast tissue, and for
marking axillary lymph nodes following a previous lymph node biopsy.
Among its areas of application are marking of suspicious tissues, marking of lesions prior to or during chemotherapy,
and marking the site of a biopsy. Likewise, the site of a removed tumor can be marked for better treatment planning
prior to radiotherapy.
It is intended to be used with magnetic resonance imaging (MRI) techniques.
Contraindications:
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The Tumark Vision MRI is not intended for use except as indicated above.
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The Tumark Vision MRI is contraindicated in patients with severe nickel allergy.
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A summary of safety and clinical performance in accordance with Article 32 of Regulation 2017/745
(implantable devices) is available on www.somatex.de.
Warnings:
Only qualified physicians with knowledge, experience and training in percutaneous soft tissue marking shall use
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the Tumark Vision MRI.
Only qualified physicians with knowledge, experience and training in MR Imaging should use the Tumark
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Vision MRI in Magnetic Resonance Imaging (MRI) procedures.
This manual does not include descriptions or instructions for surgical techniques. It is the responsibility of the
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physician performing any procedure to determine the appropriateness of the procedure to be performed and of
the use of this device and to determine the specific technique for each patient.
When implanting a clip marker near a breast implant, handle with care to avoid puncturing the breast implant.
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The Tumark Vision MRI should only be used before the expiration date and only if the packaging is unopened
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and undamaged. Product sterility can only be guaranteed, if these criteria are met. If the expiration date is
exceeded or if the packaging is damaged or opened before use, the product should not be used and the
distributor or manufacturer, SOMATEX, should be contacted.
The product is intended for single use only: DO NOT reuse or resterilize.
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When using a positioning needle, the Tumark
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bevelled Tumark Vision MRI cannula tip opening should protrude fully out of the positioning needle, and the
user should be able to gauge this protrusion in order to be able to apply the clip marker safely and not place it
too far into the tissue.
Note that the size of the image artifact depends on the sequence and the orientation towards the B
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Therefore the actual position of the cannula tip may differ from the position of the artifact tip.
Care must be taken, when marking axillary lymph nodes in particular, NOT to trap nearby blood vessels with
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the clip marker and not to damage a nearby nerve.
If the clip marker, which was placed in the area of the axillary lymph nodes, cannot be found again, it is important
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to identify and ensure its location.
Precautions:
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The Tumark Vision MRI clip marker is made from a nickel-titanium alloy (Nitinol), which is why the product is
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contraindicated in patients with severe nickel allergy.
Make sure that the slide button remains in the retracted position while the cannula is being put in position.
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The clip marker must be placed by pushing the slide button forward as far as possible to the stop position.
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There is risk of injury due to the sharp cannula tip. Use care especially when unpacking the cannula.
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Pay attention to the dimensions of the clip marker in relation to the size of the tissue area being marked (see
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Product Description).
In rare cases the expansion of the clip marker may be delayed. Visibility in radiological imaging might be
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compromised until full expansion.
Information about materials used:
The implantable clip marker is made from a nickel-titanium alloy (Nitinol).
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The cannula is made from a nickel-cobalt alloy (MP35N).
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Vision MRI must be checked for compatibility in advance. The
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Keep for future reference
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Vision MRI is unsafe and can result
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field.
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