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Quality and Safety

The Echopulse® includes several components designed for patient and physician safety, as well as high-quality treatment.

 

Echotherapy ensures:

• a non-invasive treatment

• no hospital stay requirement, nor any general anesthesia

• a safe treatment with on-going monitoring, controlled supplied energy, a skin cooling system to avoid any burns and no ionizing radiation

 

The Echopulse® solution provides doctors with:

• to get millimetric accuracy of treatment

• to get a real-time control through the ultrasound images

• to be able to stop the treatment at any time with the user interface or the emergency stop button

• to safely treat his/her patient thanks to the movement sensors and cooling system

 

Equipped with a breakthrough electronically monitored and controlled power source as well as an integrated control system, the device is safe.

This device has been developed and is manufactured according to state of the art medical standards as well as breakthrough technology.

During the manufacturing phase, we contract certified international vendors, who meet our scientific and technical competencies with state-of-the-art know-how in medical device manufacturing.

Theraclion is ISO 13485:2003 certified and Echopulse is CE-marked for breast fibroadenoma and thyroid nodule.

Theraclion and its team will assist you through detailed training in order to ensure a rapid and safe device handling.

 

 

Echopulse® and its accessories are class IIB medical devices designed and marketed by Theraclion for the treatment of breast fibroadenomas and benign thyroid nodules.
They are regulated health products which bear the CE marking as required by law. Please read the user guide carefully. 

 

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