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 familiarize yourself with all instructions before using the Tumark
life-threatening or severe injury to the patient or user and to damage or malfunction of the device.
Indications:
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The Tumark Vision 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 Vision 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 Vision.
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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 Vision tissue site marking system is only sterile if the indicator on the package is green, if used
before the expiration date and if package is unopened and undamaged. DO NOT use if indicator is not green,
after the expiration date or if package 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. Use care especially when unpacking the cannula.
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The cannula of Tumark
Danger of injury!
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Consider the size of the clip marker in relation to the area to be marked (see picture 1).
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In rare cases the expansion of the marker may be delayed. Visibility in radiological imaging might be
compromised until full expansion.
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.
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Vision may be contraindicated in patients who suffer from a severe nickel allergy.
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Vision is NOT made of MRI-compatible metals. NOT suitable for MRI safety area.
Vision as an application system for clip markers is not suitable for use in MRI.
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Vision is unsafe and can result in

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Keep for future reference
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Vision will produce the