zebris Medical GmbH
FDM Technical Data and Operating Instructions
Page 10/54
2.2.4 General safety instructions
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 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.
Measurement and analysis results should always be interpreted in the light of the clinical
history of the patient and in the context of other diagnostic tests by a trained person
proven and tested for their relevance.
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.
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 con-
tacted in all cases of fault or doubt.
If any fluids should penetrate the device, it is mandatory for the device to undergo a tech-
nical, safety test. Damaged plug connections and leads are to be replaced by an author-
ized service technician. The device must be put out of operation immediately, marked as
"Not working“ and prevented from being used by removing the mains cable.
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
Be sure that all the mains and connection cables are laid safely and that they are pro-
tected against stepping on, so that nobody can trip over them. Check all the cables and
the connection plug regularly for any damage. Damaged power Supplys and cables have
to be replaced before further operation
Never try to service the measuring system in any other way as described in the provided
user manual. When removing the covers, you may expose yourself to lethal voltages or
other risks.
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.
