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Additionally in Germany it is applicable as follows:
• The device is manufactured according to the medical products law (MPG).
• The device is subject to the medical products operator's regulation (MPBetreibV).
• Operator and user are obligated to strictly observe the operator's regulation in all
aspects.
• For all other states of the European Community national laws and regulations for
operation of medical products are valid.
Explanation of signs on the CE label
Observe the instruction manual!
Application component of type BF. Application components are not suitable to
be used for direct application at the heart.
Symbol for the marking of electric appliances and electronic devices.
Manufacturer
hofmann gmbh, frankenstraße 16, 63776 mömbris
fon: +49 (0) 6029-99890, GERMANY
www.sanowell.com
Version: August 2013
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