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Tumark
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 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.
Intended use and indications for use:
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The Tumark
MRI is intended for the percutaneous marking of soft tissue, such as breast tissue.
Among its areas of application are marking of lesions prior to or during chemotherapy, marking the site of a biopsy
or of a removed tumor, or prior to radiotherapy for better treatment planning.
It is intended to be used with magnetic resonance imaging (MRI) techniques.
Contraindications:
®
The Tumark
MRI is not intended for use except as indicated above.
®
The Tumark
MRI is contraindicated in patients with severe nickel allergy.
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
®
the Tumark
MRI.
Only qualified physicians with knowledge, experience and training in MR Imaging should use the Tumark
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 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.
®
The Tumark
MRI should only be used before the expiry date and only if the packaging is unopened and
undamaged. Product sterility can only be guaranteed if these criteria are met. If the expiry 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.
When using a positioning needle, the Tumark
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MRI cannula tip opening should protrude fully out of the positioning needle, and the user should be
Tumark
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
Therefore the actual position of the cannula tip may differ from the position of the artifact tip.
Precautions:
®
The Tumark
MRI clip marker is made from a nickel-titanium alloy (Nitinol), which is why the product is
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.
The clip marker must be placed by pushing the slide button forward as far as possible to the stop position.
There is risk of injury due to the sharp cannula tip. Use care especially when unpacking the cannula.
Pay attention to the dimensions of the clip marker in relation to the size of the tissue area being marked (see
Product Description).
In rare cases the expansion of the clip marker may be delayed. Visibility in radiological imaging might be
compromised until full expansion.
Information about materials used:
The implantable clip marker is made from a nickel-titanium alloy (Nitinol).
The cannula is made from an alloy of cobalt and chrome.
MRI Safety Information:
®
The Tumark
application system (cannula with handle) and the marker under the following conditions:
static magnetic field of 1.5 Tesla and 3.0 Tesla with
MR
theoretically estimated maximum – averaged across the whole body – specific absorption rate
conditional
(whole body averaged SAR) of 2 W/kg for scanning of 20 minutes.
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MRI must be checked for compatibility in advance. The bevelled
MRI is conditionally MR safe. A patient can safely undergo an MRI procedure with the
6/36
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MRI is unsafe and can result in life-
30°C
5°C
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Keep for future reference
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MRI
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