En - English - SOMATEX TUMARK Q Instrucciones De Uso

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Tumark Q
E N - E N G L I S H
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 Q is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous
procedure. It is indicated for use to radiographically and radiologically mark the location in breasts tissue following
an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI)
techniques.
Purpose of the Device:
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The Tumark Q serves for marking of soft breast tissue which ensures radiographical and radiological visibility using
ultrasound and mammography and therefore easy lesion localization at a later date. The marker may be implanted
to mark the location of a biopsy sampling point or the location of a removed tumor. In addition, it may be implanted
in lesions prior to or during chemotherapy.
Contraindications:

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The Tumark Q 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 should
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use the Tumark Q.
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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 type of procedure to be performed
and the use of this product and to determine the specific technique for each patient
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DO NOT use the system in patients with breast implants.
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The Tumark Q tissue site marking system is only sterile if used before the expiration date and if package is
unopened and undamaged. DO NOT use after the expiration date or if package is open or damaged.
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Single patient use only. DO NOT reuse or resterilize.
Precautions:
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Make sure that the slide-button does not change its backward position while placing the cannula.
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The marker must be placed by pushing the slide-button forward as far as possible.
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Cannula tip is sharp. Use care especially while unpacking the cannula.
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Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.
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 meting 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
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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Q is contraindicated in patients who suffer from a severe nickel allergy.
Q as an application system for clip markers is not suitable for use in MRI.
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EN - ENGLISH

Q is unsafe and can result in life
.
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Q will produce the following