Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 13 of 16
8. Reporting obligation
All serious incidents occurring in connection with the product shall be reported to the manufacturer (
K.H.
Dewert GmbH
) and to the
competent authority
of the Member State in which the user and/or the patient
resides.
Member State
Competent authority
Web
Estonia
Health Board
Terviseamet
https://www.terviseamet.ee/en
Finland
Fimea
https://www.fimea.fi/web/en
Iceland
Iceland Medicines
Agency
https://www.ima.is/
Luxembourg
CNS
https://cns.public.lu/en
Malta
MCCAA
https://mccaa.org.mt/
Switzerland
Swiss medic
https://www.swissmedic.ch/swissmedic/de/home.html
A serious incident is an incident that directly or indirectly had, could have had, or may have had any of the
following consequences:
•
death of a patient, user or other person,
•
temporary or permanent serious deterioration of the state of health of a patient, user or other person,
•
serious threat to public health.
9. Disposal
•
Packaging
Safety notice: Pay attention to sharp edges and pointed objects during disposal!
The packaging materials produced are mainly:
o
Cardboard/Paper
o
Plastic
o
Wood (when delivered on a pallet)
Please observe the local regulations for waste disposal and preferably recycle the materials.
As a manufacturer, we are licensed as a participant in the Dual System in accordance with the German
Packaging Act (VerpackG) and therefore bear the disposal costs, meaning you can dispose of the packaging
free of charge.
•
Product
Safety notices:
o
Pay attention to sharp edges and pointed objects!
o
When transporting the table, only take hold of the underframe,
NOT
the upper frame.
o
In order to prevent accidents later on, the no longer used product must be rendered unusable
immediately, e.g. by disconnecting the power cable.
Please observe the local regulations for waste disposal and preferably recycle the materials.
Tables with electromotive height adjustment are subject to WEEE Directive 2012/19/EU. These old devices
must be collected, recycled and disposed of in an environmentally sound manner. Use the return and
collection systems available to you for this purpose.
