English - SOMATEX MRI Tuloc Gebrauchsanweisung

MRI Tuloc
E N G L I S H
Read carefully before use
Intended use:
The product is intended as a preoperative marker of non-palpable suspected breast lesions to facilitate the
intraoperative localization of the findings by the surgeon.
Product description:
The MRI Tuloc consists of a hypodermic needle and a preloaded marking wire with distal double arches (Figure 1).
The marker wire has a marking (Figure 1) which provides the user with an orientation guide during the operation.
Contraindications:
All contra-indications applicable to the relevant area of application, as known according to the rules of the art of
medicine and anticipated for the use of cannulas and marker systems for preoperative marking of breast lesions,
shall apply.
Possible known complications:
Wire dislocation, accidental cutting of wire, wire break, bleedings, infections, aesthetic complications
Warnings:

Only qualified physicians with the required knowledge, experience and training shall use the product.

Only qualified physicians with knowledge, experience and training in MR Imaging should use the
MRI Tuloc in Magnetic Resonance Imaging (MRI) procedures.

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.

The product 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.

Note that the size of the image artifact depends on the sequence and the orientation towards the B
Therefore the actual position of the cannula tip may differ from the position of the artifact tip.

Single patient use only. DO NOT reuse or resterilize.
Warning:
The company SOMATEX does not assume any liability for the use of this product or its components in case of re-
sterilization or reuse. This product may not be reused after a single application. The quality of the materials, coats
and adhesive joints can degrade. Safe use is not guaranteed any longer. The product that is already used once is
not designed for the required cleaning and sterilization processes. The sterility of the reprocessed disposable
products is therefore not guaranteed. The risk of unwanted injuries and infections, especially cross-infections
between patient and medical staff inappropriately increases.
MRI Safety Information:
MRI Tuloc is MR conditional. A patient with MRI Tuloc can be safely scanned in an MR system
meeting the following conditions:

static magnetic field of 1.5 Tesla and 3.0 Tesla with

theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR):
MR

conditional
of 2.00 W/kg at 1.5 Tesla;

of 1.77 W/kg at 3.0 Tesla.
Non-clinical tests were performed on the following systems:

1.5 Tesla Siemens Magnetom Avanto (Siemens Medical, Erlangen, Germany) MRI with Software Numaris
4, syngo MR (Version "B13, N4_VB13A_LATEST_20060607_P29");

3.0 Tesla Siemens Magnetom Trio (Siemens Medical, Erlangen, Germany) MRI with Software Numaris 4,
syngo MR (Version "B17").
Under the scanning conditions defined above, it is expected that MRI Tuloc will produce the following maximum
RF-related temperature rise:

at 1.5 Tesla: 2.24 °C (2.00 W/kg SAR) after 20 min of continuous scanning,

at 3.0 Tesla: 6.00 °C (1.77 W/kg SAR) after 15 min of continuous scanning.
Under the scanning conditions defined above, it is expected that MRI Tuloc will produce the following maximum
image artefacts:

at 1.5 Tesla: 8.9 mm spin echo sequence; 10.0 mm gradient echo sequence,

at 3.0 Tesla: 52.1 mm spin echo sequence; 47.8 mm gradient echo sequence.
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