En - English - SOMATEX Tumark Vision Gebrauchsanweisung

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Tumark Vision
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
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 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.
Contraindications:
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The Tumark Vision is not intended for use except as indicated above.
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The Tumark® Vision cannula is not suitable for use with magnetic resonance imaging (MRI).
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The Tumark® Vision 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.
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 should only be used if the indicator on the packaging is green, only before the expiration
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date and only if the packaging is unopened and undamaged. Product sterility can only be guaranteed if these
criteria are met. If the indicator is not green, 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 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.
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 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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The cannula of Tumark
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Danger of injury!
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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MRI Safety Information application system (cannula with handle):
Unlike the clip marker, the Tumark
MRI scanner.
MR unsafe
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Vision is NOT made of MRI-compatible metals. NOT suitable for MRI safety area.
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Vision cannula application device is not suitable for use in an
6/36
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Vision must be checked for compatibility in advance. The
30°C
5°C

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Keep for future reference
Vision is unsafe and can result in