SOMATEX Tumark Vision Mode D'emploi page 7

®
Tumark Vision
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: 4.3 mm spin echo sequence; 5.2 mm gradient echo sequence,

at 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 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 spherical shape (1). The symbol of the clip marker shape is depicted on the handle (4).
Directions for Use:
1. Before opening, make sure that the packaging is not already open or damaged, that the indicator on the
packaging is green, and that it is within the expiry date.
2. Disinfect the puncture area and cover the area around it with sterile drapes if required.
3. Use suitable imaging methods (ultrasound, mammography) to identify the target area. NOTE: the Tumark
Vision cannula is not suitable for the MRI safety zone.
4. Open the packaging and remove the product from packaging.
5. Remove the cannula protection hose from the outer cannula by twisting.
6. Use the cannula (2) to puncture the target area, and insert into the tissue. The depth of insertion can be read
from the markings on the cannula when positioning the cannula tip.
7. Check the position of the cannula tip using suitable imaging techniques, and adjust if appropriate.
8. Place the clip marker (1) by pushing the slide button (3) forward as far as it will go.
9. Verify and record the position of the clip marker (1).
10. Remove the cannula (2).
11. Treat the wound.
12. After use: dispose the application device properly, following internal guidelines if appropriate; however, at
least one suitable container intended for contaminated cannulas should be provided to ensure safe disposal.
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 could 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.
7/78
schematic representation
dimensions of clip marker
5°C
EN - ENGLISH
®
Vision will produce the
®
Vision will produce the
4
30°C
®