En - English - SOMATEX TUMARK Professional Gebrauchsanweisung

®
Tumark Professional
6. Position der Kanülenspitze mit geeigneten bildgebenden Verfahren überprüfen und gegebenenfalls
korrigieren.
7. Marker (1) platzieren, indem Sie den Schieber (3) fest bis zum Anschlag vorschieben.
8. Lage des Markers (1) überprüfen und dokumentieren.
9. Kanüle (2) entfernen.
10. Wundstelle versorgen.
11. Nach der Behandlung fachgerechte Entsorgung der Kanüle (2) in einen geeigneten Kanülenbehälter.
Warnhinweis:
Die Firma SOMATEX lehnt im Falle einer Resterilisation oder Wiederverwendung jede Verantwortung für die
Nutzung dieses Produktes oder einzelner Produktbestandteile ab. Dieses Produkt darf nach einmaliger
Anwendung nicht wieder
Klebeverbindungen können sich verschlechtern. Eine sichere Anwendung ist nicht mehr gewährleistet. Das
Produkt ist nach einmaliger Verwendung nicht für die notwendigen Reinigungs- und Sterilisierungsprozesse
ausgelegt. Die Sterilität der wiederaufbereiteten Einmalprodukte ist somit nicht gewährleistet. Das Risiko von
ungewollten Verletzungen und Infektionen, insbesondere Kreuzinfektionen bei Patient und medizinischem
Personal steigt unangemessen.
Lagerungshinweise:
Dunkel und trocken (Luftfeuchtigkeit 30–65 %) bei 5–30 °C lagern.
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
result in life threatening or severe injury to the patient or user and to damage or malfunction of the device.
Indications:
®
Tumark Professional
The
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 Professional
The
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 Professional
The

Tumark
The use of the
nickel allergy.
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
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 Professional
The
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.

Single patient use only. DO NOT reuse or resterilize.
Precautions:

Make sure that the slide-button does not change its backward position while placing the cannula.

The marker must be placed by pushing the slide-button forward as far as possible.

Cannula tip is sharp. Use care especially while unpacking the cannula.

Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.
Device Description:
®
Tumark Professional
The
absorbable nickel-titanium marker (1), an introducer cannula (2) and a plastic handle. The introducer cannula is
5/28
verwendet werden. Die
is intended to attach a marker to soft tissue at the surgical site during an open or a
serves for marking of soft breast tissue which ensures radiographical and
is not intended for use except as indicated above.
®
Professional
system is contraindicated in patients who suffer from a severe
®
Professional
.
tissue site marking system is only sterile if the indicator is green, if used
is a sterile, single use, preloaded tissue site marking system consisting of a non-
Qualität der Materialien,
®
Tumark Professional

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Beschichtungen und
is unsafe and can
.