Dewert User Manual Model 2410XL - Updated 05.2021/1 MDR Page 8 of 12
Insufficient lubrication is noticeable through noise development.
A checklist for maintenance/technical inspection can be found in the appendix.
Despite regular maintenance/technical inspection, the
user
is also responsible for patient safety and proper
and reliable functioning.
As the user, make sure that the table is in good working order prior to each use (visual inspection).
In the event of any abnormalities, take the table out of service immediately and inform the operator.
Replace damaged or worn components immediately and do not use the table until it has been repaired.
The table complies with the safety regulations prescribed at the time it was placed on the market. Improper
repairs and structural modifications (disassembly of original parts, installation of third-party parts, etc.) may
result in hazards for patients and users. In the event of uncoordinated modifications to the table, the
Declaration of Conformity loses its validity and the warranty shall become null and void.
We cannot be held liable for damages resulting from uncoordinated modifications.
Only original Dewert spare parts may be used.
Gas springs are wearing parts whose function may be impaired over the years depending on the frequency of
use. These components can be replaced without too much effort. Please request the corresponding
installation diagram, if required. Replacement parts can be obtained directly from Dewert.
7. 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.
