Tumark
®
Q
6/72
EN - ENGLISH
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E N - E N G L I S H
Read instructions before use
Keep for future reference
Important Information:
Read this instruction manual thoroughly and be familiar with its contents prior to use of the
Tumark
®
Q
. Failure to
read the entire manual and familiarize yourself with all instructions before using the
Tumark
®
Q
is unsafe and can
result in life-threatening or severe injury to the patient or user and to damage or malfunction of the device.
Intended use and indications for use:
The
Tumark
®
Q
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.
Contraindications:
The
Tumark
®
Q
is not intended for use except as indicated above.
The
Tumark
®
Q
cannula is not suitable for use with magnetic resonance imaging (MRI).
The
Tumark
®
Q
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 at www.somatex.de.
Warnings:
Only qualified physicians with knowledge, experience and training in percutaneous soft tissue marking shall use
the
Tumark
®
Q
.
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
®
Q
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
®
Q
must be checked for compatibility in advance. The bevelled
Tumark
®
Q
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.
Precautions:
The
Tumark
®
Q
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.
The cannula of
Tumark
®
Q
is NOT made of MRI-compatible metals. NOT suitable for MRI safety area. Danger
of injury!
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).
MRI Safety Information application system (cannula with handle):
MR unsafe
Unlike the clip marker, the
Tumark
®
Q
cannula application device is not suitable for use in an MRI
scanner.
MRI Safety Information clip marker:
MR
conditional
The clip marker is conditionally MR safe. A patient can safely undergo an MRI procedure with the
clip marker under the following conditions:
static magnetic field up to 3.0 Tesla with
theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR)
of 2 W/kg.