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Tumark
Eye
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 expiration 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
Eye 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.
Storage Instructions:
Store in a dry and cool area at a temperature of 5 – 30 °C.
Keep away from sunlight and heat.
Any serious events that occur in relation to the product should be reported to SOMATEX Medical
Technologies GmbH as well as the competent national authority.
8/16
30°C
5°C
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