Regarding Implantation - ewimed drainova Instructions

Ensuring traceability.
Make a note of the LOT­number in the prescription, in the catheter passport and in the patient's medi­
cal file in order to ensure full traceability.
Possible complications or undesired side-effects.
Re­expansion pulmonary oedema, pneumothorax, hemothorax, tear or injury of the lung, liver or
other organs, hypotension, circulatory collapse, wound infection, empyema, serum, electolyte im­
balance, loss of protein, leakage of fluid from incision site, peritonitis, infection, development of me­
tastases, bleeding, septa in the affected body cavities, chest or abdominal pain, catheter dislocation,
hepatorenal syndrome, catheter blockage, defect catheter, defect valve, complications during explan­
tation (including residual fragments of the catheter) or failed implantation.
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Please note: Effusion drainage can cause some discomfort or be painful for the patient. Should
the patient experience severe pain, it is possible to stop or slow down the drainage flow by using
the clamp on the connection tube.
Please note: All serious incidents relating to the product must be reported to the manufacturer
and relevant authorities.
Warnings

regarding implantation

Particular care must be taken to ensure that the catheter remains sterile during
implantation.
The implantation of the catheter should be carried out under sterile conditions in an aseptic environ­
ment. As soon as the catheter is removed from it's sterile packaging, care must be taken to ensure that
it does not come into contact with unsterile objects.
The catheter may become electrostatically charged attracting particles from the surrounding environ­
ment, which can cling to the silicone. It is therefore important to carry out the implantation in a speedy
manner. Correct use minimises risk of infection.
Exercise caution when carrying out the implantation.
When puncturing, take care that no surrounding tissue or organs are injured. Should resistance be
experienced at any point during the procedure, the operation should be stopped immediately and the
reason for the resistance should be determined using a visual aid.
The guidewire (Seldinger wire) must not be pulled back through the cannula as withdrawal can cause
damage to the wire. Care must be taken that the guidewire is not inserted deeper than necessary.
Should resistance be experienced when handling the cannula or the guidewire, the operation should
be stopped immediately and the reason for the resistance should be determined using a visual aid.
Exercise caution when handling the scalpel in order to avoid unwanted injuries. When making the
incision with the scalpel take care not to damage the guidewire.
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