Idiomas disponibles
Idiomas disponibles
Q
®
TUMARK
Instruction for use (English)
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
threatening or severe injury to the patient or user and to damage or malfunction of the device.
Indications:
®
Tumark
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The
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:
®
Tumark
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The
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:
®
Tumark
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The
is not intended for use except as indicated above.
•
Tumark
The use of the
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Warnings:
Only qualified physicians with knowledge, experience and training in percutaneous soft tissue marking
•
Tumark
should use the
This manual does not include descriptions or instructions for surgical techniques. It is the responsibility of
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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
DO NOT use the system in patients with breast implants.
•
®
Tumark
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The
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package is unopened and undamaged. DO NOT use after the expiration date or if package is open or
damaged.
Single patient use only. DO NOT reuse or resterilize.
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Precautions:
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.
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Device Description:
®
Tumark
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The
is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable
nickel-titanium marker (1), an introducer cannula (2) and a plastic handle.
The introducer cannula is designed with a beveled tip for convenient introduction, 1 cm depth marks and an
ultrasound enhancement on the distal end to aid in cannula placement. The handle is equipped with a slide-button
(3) which allows for a one handed placement of the marker by pressing it forward. A safety catch system
prevents the slide-button to inadvertently move forward and therefore prevents a premature deployment of the
marker.
(1) Marker
-4-
®
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is contraindicated in patients who suffer from a severe nickel allergy.
®
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.
tissue site marking system is only sterile if used before the expiration date and if
(2) Cannula
®
Tumark
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is unsafe and can result in life
(3) Slide-Button
.
