SOMATEX Tumark Eye Gebrauchsanweisung Seite 7

®
Tumark Eye
MRI Safety Information application system (cannula with handle):
Unlike the clip marker, the Tumark
MRI scanner.
MR unsafe
MRI Safety Information clip marker:
The clip marker is conditionally MR safe. A patient can safely undergo an MRI procedure with the
clip marker under the following conditions:
static magnetic field up to 3.0 Tesla with

theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR)
MR

conditional
of 2 W/kg.
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 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
following maximum RF-related temperature rise:
at 1.5 Tesla: < 1,0 °C (2 W/kg SAR) after 20 min of continous scanning,

at 3.0 Tesla: < 1,0 °C (2 W/kg SAR) after 20 min of continous scanning.

Under the scanning conditions defined above, it is expected that clip marker of Tumark
following image artefacts:
at 1.5 Tesla: 3.4 mm spin echo sequence; 3.8 mm gradient echo sequence,

at 3.0 Tesla: 3.7 mm spin echo sequence; 3.9 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 handle is equipped with a slide button (3) which
allows one handed placement of the marker by pressing it forward. 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 circular shape with lateral protruding ends. The symbol of the clip marker shape is depicted on the
handle (4).
7/16
®
Eye cannula application device is not suitable for use in an
schematic representation
dimensions of the eye marker
5°C
EN - ENGLISH
®
Eye will produce the
®
Eye will produce the
4
30°C