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Tumark
MRI
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"),
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
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
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: 7.1 mm spin echo sequence, 6.5 mm gradient echo sequence
Clip Marker with 3.0 Tesla: 9.0 mm spin echo sequence, 6.5 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 U- shape (1).
1
Directions for Use:
1.
Before opening, make sure that the packaging is not already open or damaged 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.
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.
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.
Confirm the needle placement with appropriate MR imaging systems. If necessary correct the placement.
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.
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2
schematic representation
dimensions of clip marker
5°C
EN - ENGLISH
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MRI will produce the following
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MRI will produce the following
30°C
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