Most of the POLYSITE® implantable port products obtained the CE mark in June 2010 to be used for high flow rate injections of contrast medium for CT scan investigations. These are the POLYSITE® marks series 2000, 3000 and 4000 implantable port products made of titanium and polyoxymethylene with:
- a 5, 7, 8 or 10 F catheter made of silicone
- a 6, 7 or 9 F catheter made of polyurethane
In order to guarantee patient safety, all injections of contrast medium through the POLYSITE® must closely follow all of the recommendations (maximum flow rate, maximum injection rate, pre-heating the contrast medium to 37o C, using a Huber needle etc) listed in the document ‘Injection of contrast medium during CT or MRI investigations’ which you will find on each page for the POLYSITE® product. These recommendations are also included in the instructions for use leaflet and in the follow-up booklet provided with each POLYSITE®.
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Obtaining the CE certificate to use POLYSITE® for injecting contrast medium in CT and MRI scan investigations