SOMATEX Tumark Vision MRI 601590 Gebrauchsanweisung Seite 7

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Tumark Vision MRI
MRI Safety Information:
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The Tumark
with the application system (cannula with handle) and the marker under the following conditions:
static magnetic field of 1.5 Tesla and 3.0 Tesla with

MR theoretically estimated maximum – averaged across the whole body – specific absorption rate

conditional
(whole body averaged SAR) of 2 W/kg for scanning of 20 minutes.
Non-clinical tests were performed on the following systems:
3 Tesla Siemens Magnetom Trio (Siemens Medical, Erlangen, Germany) MRI with Software Numaris 4,

syngo MR (Version "B15, N4_VB15A_LATEST_20070519_P12"),
3 Tesla Siemens Magnetom Skyra (Siemens Medical, Erlangen, Germany) MRI with Software Numaris 4,

syngo MR (Version "B13, N4_VB13A_LATEST_20120616"),
1.5 Siemens Magnetom Avanto (Siemens Medical, Erlangen, Germany) MRI with Software Numaris 4,

syngo MR (Version "B13, N4_VB13A_LATEST_20060607_P29").
Under the scanning conditions defined above, it is expected that the Tumark
following maximum HF-conditional temperature rise after 20 minutes of continuous scanning:
Application system with 1.5 Tesla: 1.41 °C (2 W/kg SAR)

Application system with 3.0 Tesla: 1.07 °C (2 W/kg SAR)

Clip Marker with 1.5 Tesla: <1 °C (2 W/kg SAR)

Clip Marker with 3.0 Tesla: <1 °C (2 W/kg SAR).

Under the scanning conditions defined above, it is expected that the Tumark
following maximum image artefacts:
Application system with 1.5 Tesla: 13.4 mm spin echo sequence, 8.9 mm gradient echo sequence

Application system with 3.0 Tesla: 52.1 mm spin echo sequence, 47.8 mm gradient echo sequence

Clip Marker with 1.5 Tesla: 4.3 mm spin echo sequence, 5.2 mm gradient echo sequence

Clip Marker with 3.0 Tesla: 5.2 mm spin echo sequence, 5.8 mm gradient echo sequence.

Do not expose the implanted clip marker to unconventional and non-standardized MRI techniques other
than the ones listed above, because it has NOT BEEN TESTED for that purpose.
Product Description:
This is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker (1), an
introducer cannula (2) and a plastic handle. When new and unopened, the clip marker is contained within the
cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of
penetration, and a textured surface behind the cannula tip. The clip marker can be placed using one hand by
pushing the slide button on the plastic handle forward (3) once the fixing clip (4) has been removed. A safety catch
system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment
of the marker. The clip marker has a spherical shape (1). The symbol of the clip marker shape is depicted on the
handle (3).
1
Directions for Use:
1. Before opening, make sure that the packaging is not already open or damaged and that it is within the expiration
date.
2. Disinfect the puncture area and cover the area around it with sterile drapes if required.
3. Locate the target area by using appropriate MR imaging systems.
4. Open the packaging and remove the product from packaging.
5. Remove the fixing clip (4) from the handle and remove the cannula protection hose by twisting it from the base.
Vision MRI is conditionally MR safe. A patient can safely undergo an MRI procedure
2
schematic representation
dimensions of clip marker
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30°C
5°C
EN - ENGLISH
Vision MRI will produce the
Vision MRI will produce the
4
3