En - English - SOMATEX Tumark Eye Gebrauchsanweisung

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Tumark Eye
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.
Indications:
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The Tumark Eye 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.
Contraindications:
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The Tumark Eye is not intended for use except as indicated above.
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The use of the Tumark
Warnings:
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Only qualified physicians with knowledge, experience and training in percutaneous soft tissue marking shall
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use the Tumark Eye.
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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.
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When implanting a marker near a breast implant, handle with care to avoid puncturing the implant
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The Tumark Eye tissue site marking system is only sterile if the indicator on the package is green, if used
before the expiration date and if the packaging is unopened and undamaged. DO NOT use if indicator is not
green, after the expiration date or if the packaging is open or damaged.
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For single use only. DO NOT reuse or resterilize.
Precautions:
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Make sure that the slide button remains in the retracted position while the cannula is being put in position.
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The marker must be placed by pushing the slide button forward as far as possible to the stop position.
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Cannula tip is sharp. Proceed carefully especially when unpacking the cannula.
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The cannula of Tumark
for use in MRI safety area. Danger of injury!
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Consider the size of the clip marker in relation to the area to be marked (see figure 1).
MRI Safety Information application system:
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The Tumark
MR unsafe
MRI Safety Information clip marker:
Clip markers, which have already been placed inside a patient, are MR safe. A patient with a clip
marker can be safely scanned in an MR system meeting the following conditions:
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static magnetic field up to 3.0 Tesla with
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theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR)
MR safe
of 2 W/kg.
Non-clinical tests were performed on the following systems:
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1.5 Tesla Siemens Magnetom Avanto (Siemens Medical, Erlangen, Germany) MRI with software Numaris 4,
syngo MR (Version "B13, N4_VB13A_LATEST_20060607_P29"),
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3 Tesla Siemens Magnetom Skyra (Siemens Medical, Erlangen, Germany) MRI with software Numaris 4,
syngo MR (Version "D11, N4_VB11D_LATEST_20110129_P3").
Under the scanning conditions defined above, it is expected that clip marker of Tumark
following maximum RF-related temperature rise:
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at 1.5 Tesla: < 1,0 °C (2 W/kg SAR) after 20 min of continous scanning,
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at 3.0 Tesla: < 1,0 °C (2 W/kg SAR) after 20 min of continous scanning.
Under the scanning conditions defined above, it is expected that clip marker of Tumark
following image artefacts:
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at 1.5 Tesla: 3.4 mm spin echo sequence; 3.8 mm gradient echo sequence,
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at 3.0 Tesla: 3.7 mm spin echo sequence; 3.9 mm gradient echo sequence.
Do not expose the implanted clip marker to unconventional and non-standardized MRI techniques other
than the ones listed above, because it has NOT BEEN TESTED for that purpose.
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Eye may be contraindicated in patients who suffer from a severe nickel allergy.
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Eye is NOT made of MRI-compatible metals. The application system is NOT suitable
Eye as an application system for clip markers is not suitable for use in MRI.
5/8
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Eye is unsafe and can result in life-

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Keep for future reference
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Eye will produce the
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Eye will produce the