zebris Medical GmbH
FDM Technical Data and Operating Instructions
Page 6/36
Instructions concerning patients safety
The application and operation of the system and also the evaluation of the measuring
data and their interpretation may only be carried out by trained qualified personnel. The
manufacturer assumes no liability for any injury to persons, damage to property, or loss
of data due to improper use of the software, the device or its component parts.
The measuring system must be checked at regular intervals to make sure it is
functioning properly. More details on this can be found in the section, "Maintenance of
the Device" in this User Manual.
The patients’ data and measuring data may only be copied, moved, or deleted using the
data-base function provided by the zebris application programs. In the case of data
being changed intentionally without using the database functions, the user alone bears
the full risks involved.
The platform must be set up on a slip-proof underlay or installed in a catwalk, so as to
exclude any danger to the test person caused by the platform sliding.
Should any measures for treatment be taken on the basis of the measuring results, the
measuring system may only be implemented as a supplementary means for evaluation
by an expert. On no account can, or may invasive measures, or measures endangering
the patient be carried out solely on the basis of the measuring results without further
verification of the measuring data by additional methods.
Prohibited Use
We warn explicitly against improper or prohibited use of the measuring system. This
includes all the prohibitions included in the section on "Personal Safety, Warnings, and
Prohibitions".
The measuring system must not be put into operation by anyone who has not been
familiarized in detail first by the trained personnel.
Should malfunctions and/or defects be determined or suspected, the device must be put
out of operation immediately, marked as "Not working“ and prevented from being used
by removing the mains cable.
Should there be any detectable damage to the device or component parts, they should
be returned to the manufacturer for a safety check. It is not permissible to continue
using the device or its component parts, as severe damage and serious injuries - even
lethal injuries - may result. The manufacturer or authorized sales partner must always
be contacted in all cases of fault or doubt.
We also point out that if any changes are made to this certified device or its accessories
without the prior written consent of zebris, your legal right to operate the device will be
nullified.
zebris measuring systems may not be operated in any other environmental conditions to
those listed in the section, "Specifications", (e.g. in wet zones, moisture-prone areas, or
in climatic, vacuum, hyperbaric or decompression chambers, etc.)
