Disclaimer

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.
The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.

FAQ

Below is a list of frequently asked questions from patients. Please note that the below information do not replace the information given in the instruction for use. Please refer to the information for use received with your Smart Charger for further information or contact your physician.

How long should I charge the alfapump®?

The charging time depends on the amount of ascites being moved per day; if 700 ml of ascites is the programmed daily volume, approximately 30 minutes per day (two times15 minutes for best results) is usually sufficient but depends on charger-to-pump contact.

If you missed charging for one day, the charging time the next day will be approximately twice as long. If you missed charging for more than 2 days or 3 days, the alfapump® might stop working and will need to be charged before it’s able to move ascites again.

How can I make sure the alfapump is charging properly?

The green charging indicators on the Smart Charger will flash when the alfapump® is charging.

How long should I charge the Smart Charger?

The charging time depends on the battery status. We recommend always returning your Smart Charger to the Docking Station when not using it to charge the alfapump®.

Can I charge the alfapump while wearing clothes?

Charging directly over the skin is preferable, but the alfapump® can also be charged through thin clothes. It must be ensured that the clothing does not contain metal parts underneath the Smart Charger.

Can I fly and pass the X-Ray at the airport?

Yes, you can, but always carry the patient implant card with you.

Do I have to bring my Smart Charger and Docking Station to my follow-up visits?

Yes, you need to bring your Smart Charger with you to every follow-up visit. However, you do not need to bring the Docking Station. Please make sure your Smart Charger is charged prior to each visit.

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